Trial Outcomes & Findings for Trastuzumab and Vinorelbine in Advanced Breast Cancer (NCT NCT01185509)

NCT ID: NCT01185509

Last Updated: 2019-01-23

Results Overview

ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 31 participants
• Primary outcome timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).
• Results posted on: 2019-01-23

Participant Flow

Patients enrolled from November 2010 through July 2014.

Participant milestones

Measure	Trastuzumab and Vinorelbine - Cohort A Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Overall Study STARTED	11	20
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	11	20

Reasons for withdrawal

Measure	Trastuzumab and Vinorelbine - Cohort A Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Overall Study Progression/Relapse	9	15
Overall Study Physician Decision	2	2
Overall Study Withdrawal by Subject	0	1
Overall Study Death	0	1
Overall Study Intercurrent Illness	0	1

Baseline Characteristics

Trastuzumab and Vinorelbine in Advanced Breast Cancer

Baseline characteristics by cohort

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Total n=31 Participants Total of all reporting groups
Age, Continuous	50 years n=5 Participants	54 years n=7 Participants	54 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	20 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	20 participants n=7 Participants	31 participants n=5 Participants
Estrogen Receptor Status at Metastatic Diagnosis Positive	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Estrogen Receptor Status at Metastatic Diagnosis Negative	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Estrogen Receptor Status at Metastatic Diagnosis Unknown	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Progesterone Receptor Status at Metastatic Diagnosis Positive	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Progesterone Receptor Status at Metastatic Diagnosis Negative	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants
Progesterone Receptor Status at Metastatic Diagnosis Unknown	0 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).

Population: The analysis dataset is comprised of all treated patients.

ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Outcome measures

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Objective Response Rate (ORR)	18.2 percentage of patients Interval 2.3 to 51.8	5.0 percentage of patients Interval 0.1 to 24.9

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).

Population: The analysis dataset is comprised of all treated patients.

CBR was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration

Outcome measures

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Clinical Benefit Rate (CBR)	63.6 percentage of patients Interval 30.8 to 89.1	20.0 percentage of patients Interval 5.7 to 43.7

SECONDARY outcome

Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months.

Population: The analysis dataset is comprised of all treated patients.

PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

Outcome measures

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Progression-Free Survival (PFS)	6.9 months Interval 5.4 to Follow-up is not long enough/Data is not mature to provide upper bound 95% confidence interval (CI).	2.7 months Interval 2.6 to Follow-up is not long enough/Data is not mature to provide upper bound 95% CI.

SECONDARY outcome

Timeframe: Assessed at baseline

Population: The CTCs in cohort A were analyzed using a non-CLIA approved assay and thus it was felt that the outcome data for this cohort were not evaluable. A new CLIA approved assay was used for the main cohort.

CTCs levels were determined based on established methods.

Outcome measures

Measure	Trastuzumab and Vinorelbine - Cohort A n=20 Participants Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Baseline Level of Circulating Tumor Cells (CTCs)	5.5 cells per 7.5 ml blood Interval 1.0 to 249.0	—

Adverse Events

Trastuzumab and Vinorelbine - Cohort A

Serious events: 9 serious events

Other events: 11 other events

Deaths: 0 deaths

Trastuzumab and Vinorelbine - Main Cohort

Serious events: 11 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 participants at risk Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 participants at risk Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Infections and infestations Abdominal infection	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Immune system disorders Allergic reaction	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Anemia	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Ascites	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Creatinine increased	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Febrile neutropenia	45.5% 5/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Hepatobiliary disorders Hepatic failure	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infections and infestations - Other	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Intracranial hemorrhage	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Investigations - Other	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Lymphocyte count decreased	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Mediastinal hemorrhage	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	63.6% 7/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Urinary tract infection	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.

Other adverse events

Measure	Trastuzumab and Vinorelbine - Cohort A n=11 participants at risk Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.	Trastuzumab and Vinorelbine - Main Cohort n=20 participants at risk Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio \> 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
Eye disorders Blurred vision	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Alanine aminotransferase increased	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Alkaline phosphatase increased	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Anemia	54.5% 6/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	40.0% 8/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Anorexia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	25.0% 5/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Anxiety	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	30.0% 6/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Atelectasis	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Atrial fibrillation	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Back pain	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Bloating	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Blood bilirubin increased	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Bone pain	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Reproductive system and breast disorders Breast pain	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Eye disorders Cataract	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	35.0% 7/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Creatinine increased	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Depressed level of consciousness	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Depression	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Dizziness	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Eye disorders Dry eye	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dyspepsia	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dysphagia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	40.0% 8/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Edema limbs	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Enterocolitis infectious	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Erythema multiforme	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	72.7% 8/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	65.0% 13/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Febrile neutropenia	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Fecal incontinence	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Fever	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Flatulence	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Eye disorders Floaters	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Flu like symptoms	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastroesophageal reflux disease	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastrointestinal disorders - Other	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders General disorders and administration site conditions - Other	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Headache	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Hemorrhoids	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Hepatobiliary disorders Hepatobiliary disorders - Other	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Hip fracture	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperglycemia	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypertension	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypomagnesemia	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyponatremia	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Infusion related reaction	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations INR increased	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Insomnia	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Laryngitis	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Lymph node pain	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Memory impairment	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Mucositis oral	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Nasal congestion	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	35.0% 7/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Neck pain	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Non-cardiac chest pain	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Otitis media	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
General disorders Pain	27.3% 3/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	15.0% 3/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Paronychia	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral motor neuropathy	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	25.0% 5/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral sensory neuropathy	36.4% 4/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	20.0% 4/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Pruritus	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash acneiform	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Sinusitis	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Skin infection	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Somnolence	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Syncope	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Tinnitus	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Toothache	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Tremor	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Urinary retention	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Infections and infestations Urinary tract infection	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Renal and urinary disorders Urinary urgency	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	0.00% 0/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	18.2% 2/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations Weight loss	0.00% 0/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	10.0% 2/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.
Investigations White blood cell decreased	9.1% 1/11 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.	5.0% 1/20 • Assessed day 1 of each cycle throughout treatment. Median follow-up was 2.7 months. Based on common terminology criteria for adverse events version 4(CTCAEv4), maximum grade toxicity by type was first calculated for AEs with trastuzumab and/or vinorelbine treatment-attribution of possibly, probably or definite. Grade 3 or higher AEs were classified as serious and grade 1-2 AEs were classified as other. No further data is available to specify classification of other beyond the general term.

Additional Information

Ian Krop, MD, PhD

Dana-Farber Cancer Institute

Phone: 617.632.6973

Email: Ian_Krop@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place