Trial Outcomes & Findings for Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer (NCT NCT00617942)
NCT ID: NCT00617942
Last Updated: 2020-06-11
Results Overview
These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
1 year
Results posted on
2020-06-11
Participant Flow
Participant milestones
| Measure |
Cohort 1
Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
Cohort 2
Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
23
|
|
Overall Study
COMPLETED
|
29
|
19
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=37 Participants
|
Cohort 2
n=23 Participants
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
51.4 years
n=5 Participants
|
51.6 years
n=7 Participants
|
51.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 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
|
37 participants
n=5 Participants
|
23 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThese numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden.
Outcome measures
| Measure |
Cohort 1
n=37 Participants
|
Cohort 2
n=23 Participants
|
Adjuvant Cohort 1
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
Adjuvant Cohort 2
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
|---|---|---|---|---|
|
Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;
|
12 participants
|
13 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPlease note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment.
Outcome measures
| Measure |
Cohort 1
n=37 Participants
|
Cohort 2
n=23 Participants
|
Adjuvant Cohort 1
n=29 Participants
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
Adjuvant Cohort 2
n=19 Participants
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
|---|---|---|---|---|
|
Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity
|
37 participants
|
23 participants
|
29 participants
|
19 participants
|
Adverse Events
Neo-adjuvant Cohort 1
Serious events: 7 serious events
Other events: 37 other events
Deaths: 0 deaths
Neo-adjuvant Cohort 2
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Adjuvant Cohort 1
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Adjuvant Cohort 2
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neo-adjuvant Cohort 1
n=37 participants at risk
Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
|
Neo-adjuvant Cohort 2
n=23 participants at risk
Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
|
Adjuvant Cohort 1
n=29 participants at risk
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
Adjuvant Cohort 2
n=19 participants at risk
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
|---|---|---|---|---|
|
Investigations
gr 3port infection,
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
flu
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Febrile Neutropenia
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 4 sepsis, intubated
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Diarrhea gr 2, Nausea gr 3, infection gr 3
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
infection normal ANC/viral grade 1
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 3cellulitis - breast
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 3 diarrhea, gr 2 neutropenia
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
UTI, gr 3 ANC, gr 3 HGB, Gr3 infection, Gr 2 fever and pain, gr1 rigor
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Dehydration
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
fever unknown etiology gr 1, lymphatics gr 1
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Syncopal epidose gr 3, dehydration gr 2, diabetes gr 2, anemia gr 2
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
thrombus occlusive L IJ gr 3, hypomagnesia gr 1, hypokalemia gr 1
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
dehydr gr3, chest pain gr 3,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 3 left jugular thrombis , anemia gr 2,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
left ear otitis externa gr 3, ANC 4, WBC 2 Diarrhea 1
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
vomit gr 3, Nausea gr 3, diarrhea gr2, GI bleed gr 2, Abdominal pain rg3,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
vomiting gr 3, infection Cdiff gr 3, Hypokalemia gr 1, gr 1 hypomagnesia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
right upper extremity cellulitis gr 3,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 3 ulcerative colitis exacerbation with and without gr 1 fever)
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gran mal seizure-2
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
allergic rxn
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Febrile neutropenia gr 2, Anemia 2, ANC 4,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
suicidal ideation gr 2 and depression gr 3 not related
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
post re-construction pt experienced seroma grade 2
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
hernia grade 3 secondary to surgery healing issue
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Sepsis 3, PLT 1, K, 1, Ca, 1, Hgb1, Phos, 3, Pruritis, 1
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
cardiac ischemia gr 2,
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
gr 3 abd pain, gr 1 nausea, gr 2 vomitting
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
impt medical event(gr2) abnormal stress test need for cardiac cath
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
Other adverse events
| Measure |
Neo-adjuvant Cohort 1
n=37 participants at risk
Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14
Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
|
Neo-adjuvant Cohort 2
n=23 participants at risk
Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16
|
Adjuvant Cohort 1
n=29 participants at risk
Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
Adjuvant Cohort 2
n=19 participants at risk
Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians
|
|---|---|---|---|---|
|
Investigations
WBC
|
86.5%
32/37 • Number of events 32 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
91.3%
21/23 • Number of events 21 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
41.4%
12/29 • Number of events 12 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
47.4%
9/19 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
ANC
|
86.5%
32/37 • Number of events 32 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
82.6%
19/23 • Number of events 20 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
24.1%
7/29 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
21.1%
4/19 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
plt
|
89.2%
33/37 • Number of events 33 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
87.0%
20/23 • Number of events 20 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
20.7%
6/29 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
21.1%
4/19 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
HGB
|
94.6%
35/37 • Number of events 35 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
95.7%
22/23 • Number of events 22 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
79.3%
23/29 • Number of events 23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
63.2%
12/19 • Number of events 12 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
M/A
|
27.0%
10/37 • Number of events 10 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
39.1%
9/23 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
21.1%
4/19 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
creatinine
|
18.9%
7/37 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.0%
3/23 • Number of events 3 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
10.5%
2/19 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Anorexia
|
13.5%
5/37 • Number of events 5 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
47.8%
11/23 • Number of events 11 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
36.8%
7/19 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
wt loss
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
17.4%
4/23 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Fatigue
|
75.7%
28/37 • Number of events 28 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
91.3%
21/23 • Number of events 21 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
55.2%
16/29 • Number of events 16 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
73.7%
14/19 • Number of events 14 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Rash
|
8.1%
3/37 • Number of events 3 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
65.2%
15/23 • Number of events 15 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
20.7%
6/29 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
57.9%
11/19 • Number of events 11 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
nausea
|
56.8%
21/37 • Number of events 21 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
78.3%
18/23 • Number of events 18 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
6.9%
2/29 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
52.6%
10/19 • Number of events 10 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
vomiting
|
16.2%
6/37 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
26.1%
6/23 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
6.9%
2/29 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
15.8%
3/19 • Number of events 3 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
mucositis
|
16.2%
6/37 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
39.1%
9/23 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
26.3%
5/19 • Number of events 5 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
diarrhea
|
21.6%
8/37 • Number of events 8 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
73.9%
17/23 • Number of events 17 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
36.8%
7/19 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
rhinitis
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
56.5%
13/23 • Number of events 13 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
47.4%
9/19 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
AST/ALT
|
75.7%
28/37 • Number of events 28 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
39.1%
9/23 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
37.9%
11/29 • Number of events 11 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
31.6%
6/19 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Neurosensory
|
29.7%
11/37 • Number of events 11 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
87.0%
20/23 • Number of events 20 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
89.5%
17/19 • Number of events 17 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Neuromuscular
|
24.3%
9/37 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
30.4%
7/23 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
47.4%
9/19 • Number of events 9 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
|
16.2%
6/37 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
8.7%
2/23 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
6.9%
2/29 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
K
|
32.4%
12/37 • Number of events 12 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
34.8%
8/23 • Number of events 8 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
31.6%
6/19 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Mg
|
54.1%
20/37 • Number of events 20 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
30.4%
7/23 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
20.7%
6/29 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
26.3%
5/19 • Number of events 5 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Ca
|
18.9%
7/37 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
30.4%
7/23 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
36.8%
7/19 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Phos
|
10.8%
4/37 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
17.4%
4/23 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.8%
4/29 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Infection
|
16.2%
6/37 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
26.1%
6/23 • Number of events 6 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
36.8%
7/19 • Number of events 7 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
HTN
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
13.0%
3/23 • Number of events 3 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
6.9%
2/29 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Abd pain
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
tinnuitius
|
5.4%
2/37 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
cough
|
5.4%
2/37 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
10.5%
2/19 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
chest pain
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
epistaxis
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
21.7%
5/23 • Number of events 5 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
15.8%
3/19 • Number of events 3 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
pulmonary embolism
|
2.7%
1/37 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
wt gain
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
ocular
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
17.4%
4/23 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
21.1%
4/19 • Number of events 4 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
rectal bleed
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
insomnia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
glucose
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
dyspnea
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
8.7%
2/23 • Number of events 2 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
26.3%
5/19 • Number of events 5 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
alopecia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
heartburn
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
rigors
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
edema
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
dizziness
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
headache
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
troponin
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
tachycardia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
hyperpigmentation
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
proteinuria
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
4.3%
1/23 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
SOB
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
desquam skin
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
back pain
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
DVT
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
pain breast
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
3.4%
1/29 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/19 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
mood alteration
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
chelitis
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
albumin
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
hypouricemia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
|
Investigations
Lymphopenia
|
0.00%
0/37 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/23 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
0.00%
0/29 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
5.3%
1/19 • Number of events 1 • Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
|
Additional Information
William Sikov, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place