Trial Outcomes & Findings for Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery (NCT NCT00513292)
NCT ID: NCT00513292
Last Updated: 2019-01-23
Results Overview
Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
280 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2019-01-23
Participant Flow
Total Enrolled: 282, 2 patients withdrew consent before starting treatment, 280 patients started the treatment and are eligible for primary analysis.
Participant milestones
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
142
|
|
Overall Study
COMPLETED
|
138
|
142
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=138 Participants
Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=142 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
48 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
280 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
|
138 participants
n=5 Participants
|
142 participants
n=7 Participants
|
280 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All patients who started study treatment are included in the analysis of the primary endpoint.
Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=138 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=142 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
|
56.5 percentage of participants
Interval 47.8 to 64.9
|
54.2 percentage of participants
Interval 45.7 to 62.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients who had clinical N1-3 disease prior to the start of treatment are included in the analysis of the pCR rate in the breast and axillary lymph nodes.
pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy (among those with Metastasis to movable ipsilateral axillary lymph node(s) (cN1-3) disease).
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=89 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=90 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy
|
48.3 Percentage (95% confidence Interval)
Interval 37.6 to 59.2
|
46.7 Percentage (95% confidence Interval)
Interval 36.4 to 56.9
|
SECONDARY outcome
Timeframe: Baseline, at 12 weekPopulation: All patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12.
The summary of asymptomatic decrease in LVEF.
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=130 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=137 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
decrease < 10%, below lower limit of normal (LLN)
|
0.8 Percentage of participants
|
0 Percentage of participants
|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
no decrease or decrease < 10%, still above LLN
|
92.3 Percentage of participants
|
82.5 Percentage of participants
|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
decrease 10-15%, still above lower limit of normal
|
6.2 Percentage of participants
|
11.7 Percentage of participants
|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
decrease 10-15%, below lower limit of normal (LLN)
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
decrease > 15%, still above lower limit of norm
|
0.8 Percentage of participants
|
2.9 Percentage of participants
|
|
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
decrease > 15%, below lower limit of normal
|
0 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, at 24 weekPopulation: All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.
The summary of asymptomatic changed in LVEF.
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=126 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=130 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
no decrease or decrease < 10%, still above LLN
|
83.3 Percentage of Participants
|
73.1 Percentage of Participants
|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
decrease < 10%, below lower limit of normal (LLN)
|
0.8 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
decrease 10-15%, still above lower limit of normal
|
7.9 Percentage of Participants
|
15.4 Percentage of Participants
|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
decrease 10-15%, below lower limit of normal (LLN)
|
2.4 Percentage of Participants
|
0.8 Percentage of Participants
|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
decrease > 15%, still above lower limit of normal
|
1.6 Percentage of Participants
|
6.9 Percentage of Participants
|
|
Asymptomatic Decreases From Baseline in LVEF at Week 24
decrease > 15%, below lower limit of normal (LLN)
|
4.0 Percentage of Participants
|
0.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: At 12 weekAll patients who had a MUGA or ECHO performed at week 12 are included in the summary of asymptomatic changed in LVEF at week 12. Difference from pretreatment LVEF (%) at 12 weeks \[median change from baseline Inter Quartile Range (IQR)\].
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=130 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=137 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week
|
2 percent
Interval -5.0 to 2.0
|
-3 percent
Interval -7.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, at 24 weekPopulation: All patients who had a MUGA or ECHO performed at week 24 are included in the summary of asymptomatic changed in LVEF at week 24.
Difference from pretreatment LVEF (%) at 24 weeks \[median change from baseline Inter Quartile Range (IQR)\].
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=126 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=130 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week
|
-3 percent
Interval -7.0 to 0.0
|
-4 percent
Interval -9.0 to 0.0
|
SECONDARY outcome
Timeframe: From time surgery to up to 5 yearsPopulation: All patients that underwent breast surgery were included in this analysis.
Surgery was categorized as breast conserving surgery ("Partial Mastectomy") or non-conserving surgery ("Total Mastectomy" or "Modified Radical Mastectomy). Reported below is the percentage of patients receiving "Partial Mastectomy". This was calculated by dividing the number of patients receiving "Partial Mastectomy" by the total number of patients undergoing surgery multiplied by 100 (to obtain the percentage).
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=130 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=138 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Breast Conservation
|
37.7 percentage of participants
|
39.1 percentage of participants
|
SECONDARY outcome
Timeframe: From time to registration to time of event, assessed up to 5 yearsPopulation: All patients that began protocol therapy are included in this analysis
DFS defined as inoperable progressive disease, gross residual disease following definitive surgery, local, regional or distant recurrence, contralateral breast cancer, other second primary cancers, and death prior to recurrence or second primary cancer. DFS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=138 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=142 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Disease-free Survival (DFS)
|
NA months
Too few events occurred to report a median and 95% Confidence Interval.
|
NA months
Too few events occurred to report a median and 95% Confidence Interval.
|
SECONDARY outcome
Timeframe: From time to registration to death, assessed up to 5 yearsPopulation: All patients that began protocol therapy were included in this analysis.
OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
FEC-75 Then Paclitaxel/Trastuzumab
n=138 Participants
Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
n=142 Participants
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Too few events occurred to report a median and 95% Confidence Interval.
|
NA months
Too few events occurred to report a median and 95% Confidence Interval.
|
Adverse Events
Arm A
Serious events: 19 serious events
Other events: 136 other events
Deaths: 0 deaths
Arm B
Serious events: 26 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=138 participants at risk
Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Arm B
n=142 participants at risk
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
5.8%
8/138 • Number of events 12
|
7.7%
11/142 • Number of events 14
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
2.2%
3/138 • Number of events 3
|
3.5%
5/142 • Number of events 6
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Eye disorders
Extraocular muscle paresis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/138 • Number of events 3
|
2.1%
3/142 • Number of events 3
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.9%
4/138 • Number of events 4
|
2.8%
4/142 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
6.5%
9/138 • Number of events 12
|
5.6%
8/142 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.9%
4/138 • Number of events 6
|
0.00%
0/142
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
7.2%
10/138 • Number of events 11
|
5.6%
8/142 • Number of events 10
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
5/138 • Number of events 5
|
4.2%
6/142 • Number of events 6
|
|
General disorders
Chest pain
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
General disorders
Chills
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
General disorders
Edema limbs
|
2.2%
3/138 • Number of events 3
|
2.8%
4/142 • Number of events 4
|
|
General disorders
Fatigue
|
9.4%
13/138 • Number of events 23
|
12.0%
17/142 • Number of events 23
|
|
General disorders
Fever
|
4.3%
6/138 • Number of events 7
|
2.8%
4/142 • Number of events 4
|
|
General disorders
Localized edema
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
General disorders
Pain
|
0.72%
1/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Infections and infestations
Bladder infection
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Bronchitis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Infection
|
1.4%
2/138 • Number of events 2
|
2.1%
3/142 • Number of events 4
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.4%
2/138 • Number of events 2
|
2.8%
4/142 • Number of events 4
|
|
Infections and infestations
Skin infection
|
3.6%
5/138 • Number of events 5
|
1.4%
2/142 • Number of events 2
|
|
Infections and infestations
Soft tissue infection
|
0.72%
1/138 • Number of events 2
|
0.00%
0/142
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Infections and infestations
Wound infection
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Fracture
|
0.72%
1/138 • Number of events 2
|
1.4%
2/142 • Number of events 2
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
4/138 • Number of events 7
|
1.4%
2/142 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/138 • Number of events 4
|
2.1%
3/142 • Number of events 3
|
|
Investigations
Creatinine increased
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Investigations
INR increased
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
2.2%
3/138 • Number of events 3
|
5.6%
8/142 • Number of events 12
|
|
Investigations
Lymphocyte count decreased
|
0.72%
1/138 • Number of events 3
|
4.2%
6/142 • Number of events 11
|
|
Investigations
Neutrophil count decreased
|
4.3%
6/138 • Number of events 7
|
9.2%
13/142 • Number of events 20
|
|
Investigations
Platelet count decreased
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 3
|
|
Investigations
Serum cholesterol increased
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Investigations
Weight gain
|
0.00%
0/138
|
2.1%
3/142 • Number of events 3
|
|
Investigations
Weight loss
|
2.2%
3/138 • Number of events 4
|
1.4%
2/142 • Number of events 2
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
3/138 • Number of events 4
|
4.2%
6/142 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
3/138 • Number of events 4
|
1.4%
2/142 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.72%
1/138 • Number of events 2
|
2.1%
3/142 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
2/138 • Number of events 4
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.2%
3/138 • Number of events 3
|
2.1%
3/142 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.72%
1/138 • Number of events 2
|
0.70%
1/142 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
1.4%
2/138 • Number of events 2
|
2.1%
3/142 • Number of events 3
|
|
Nervous system disorders
Encephalopathy
|
0.72%
1/138 • Number of events 2
|
0.00%
0/142
|
|
Nervous system disorders
Headache
|
4.3%
6/138 • Number of events 7
|
6.3%
9/142 • Number of events 10
|
|
Nervous system disorders
Neurological disorder NOS
|
0.72%
1/138 • Number of events 9
|
0.00%
0/142
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
5/138 • Number of events 6
|
5.6%
8/142 • Number of events 10
|
|
Nervous system disorders
Syncope
|
1.4%
2/138 • Number of events 2
|
1.4%
2/142 • Number of events 2
|
|
Nervous system disorders
Taste alteration
|
0.72%
1/138 • Number of events 4
|
0.70%
1/142 • Number of events 2
|
|
Nervous system disorders
Tremor
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Psychiatric disorders
Anxiety
|
1.4%
2/138 • Number of events 4
|
1.4%
2/142 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Psychiatric disorders
Depression
|
1.4%
2/138 • Number of events 4
|
4.9%
7/142 • Number of events 8
|
|
Psychiatric disorders
Insomnia
|
0.72%
1/138 • Number of events 3
|
3.5%
5/142 • Number of events 5
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
3/138 • Number of events 3
|
2.8%
4/142 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
7/138 • Number of events 7
|
4.9%
7/142 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.72%
1/138 • Number of events 3
|
0.70%
1/142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
9/138 • Number of events 13
|
7.7%
11/142 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.9%
4/138 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Vascular disorders
Hot flashes
|
1.4%
2/138 • Number of events 3
|
1.4%
2/142 • Number of events 2
|
|
Vascular disorders
Hypertension
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 4
|
Other adverse events
| Measure |
Arm A
n=138 participants at risk
Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
Arm B
n=142 participants at risk
Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
2.2%
3/138 • Number of events 6
|
3.5%
5/142 • Number of events 7
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
2/138 • Number of events 3
|
2.1%
3/142 • Number of events 3
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
38.4%
53/138 • Number of events 279
|
35.2%
50/142 • Number of events 269
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/138
|
1.4%
2/142 • Number of events 8
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
0.00%
0/138
|
1.4%
2/142 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
1.4%
2/138 • Number of events 2
|
3.5%
5/142 • Number of events 8
|
|
Cardiac disorders
Arrhythmia
|
2.2%
3/138 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
6.5%
9/138 • Number of events 14
|
12.7%
18/142 • Number of events 25
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
3.6%
5/138 • Number of events 7
|
2.8%
4/142 • Number of events 4
|
|
Cardiac disorders
Pericardial effusion
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 4
|
|
Cardiac disorders
Premature ventricular contractions
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Sinus arrhythmia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Cardiac disorders
Sinus bradycardia
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Cardiac disorders
Sinus tachycardia
|
6.5%
9/138 • Number of events 12
|
5.6%
8/142 • Number of events 14
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 14
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 9
|
|
Ear and labyrinth disorders
Ear disorder
|
0.72%
1/138 • Number of events 3
|
1.4%
2/142 • Number of events 2
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Ear and labyrinth disorders
External ear pain
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing loss
|
0.00%
0/138
|
0.70%
1/142 • Number of events 2
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Endocrine disorders
Hypothyroidism
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Eye disorders
Conjunctival disorder
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
1.4%
2/138 • Number of events 3
|
2.1%
3/142 • Number of events 5
|
|
Eye disorders
Extraocular muscle paresis
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Eye disorders
Eye disorder
|
0.72%
1/138 • Number of events 5
|
6.3%
9/142 • Number of events 17
|
|
Eye disorders
Eye pain
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Eye disorders
Eyelid function disorder
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Eye disorders
Vision blurred
|
8.0%
11/138 • Number of events 14
|
11.3%
16/142 • Number of events 37
|
|
Eye disorders
Watering eyes
|
1.4%
2/138 • Number of events 4
|
2.1%
3/142 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
2/138 • Number of events 2
|
2.8%
4/142 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
9/138 • Number of events 12
|
11.3%
16/142 • Number of events 24
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
41.3%
57/138 • Number of events 142
|
35.9%
51/142 • Number of events 113
|
|
Gastrointestinal disorders
Diarrhea
|
52.2%
72/138 • Number of events 172
|
55.6%
79/142 • Number of events 210
|
|
Gastrointestinal disorders
Dry mouth
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
16/138 • Number of events 48
|
16.9%
24/142 • Number of events 52
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
4/138 • Number of events 5
|
4.2%
6/142 • Number of events 9
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
33.3%
46/138 • Number of events 86
|
28.9%
41/142 • Number of events 78
|
|
Gastrointestinal disorders
Endoscopy large bowel abnormal
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal mucositis
|
1.4%
2/138 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.72%
1/138 • Number of events 2
|
0.00%
0/142
|
|
Gastrointestinal disorders
Flatulence
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Gastrointestinal disorders
Gastric mucositis
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
2.2%
3/138 • Number of events 3
|
5.6%
8/142 • Number of events 10
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.2%
3/138 • Number of events 4
|
6.3%
9/142 • Number of events 10
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/138
|
2.1%
3/142 • Number of events 3
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.2%
3/138 • Number of events 6
|
4.9%
7/142 • Number of events 9
|
|
Gastrointestinal disorders
Ileus
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Gastrointestinal disorders
Mucositis oral
|
15.2%
21/138 • Number of events 31
|
12.0%
17/142 • Number of events 31
|
|
Gastrointestinal disorders
Nausea
|
73.2%
101/138 • Number of events 325
|
76.1%
108/142 • Number of events 315
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
2/138 • Number of events 2
|
3.5%
5/142 • Number of events 5
|
|
Gastrointestinal disorders
Tooth disorder
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/138
|
2.8%
4/142 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
39.1%
54/138 • Number of events 98
|
32.4%
46/142 • Number of events 89
|
|
General disorders
Chest pain
|
3.6%
5/138 • Number of events 5
|
6.3%
9/142 • Number of events 12
|
|
General disorders
Chills
|
5.8%
8/138 • Number of events 14
|
4.9%
7/142 • Number of events 12
|
|
General disorders
Edema limbs
|
20.3%
28/138 • Number of events 47
|
20.4%
29/142 • Number of events 85
|
|
General disorders
Fatigue
|
89.9%
124/138 • Number of events 768
|
88.7%
126/142 • Number of events 711
|
|
General disorders
Fever
|
7.2%
10/138 • Number of events 11
|
14.8%
21/142 • Number of events 28
|
|
General disorders
Flu-like symptoms
|
1.4%
2/138 • Number of events 2
|
1.4%
2/142 • Number of events 2
|
|
General disorders
General symptom
|
2.2%
3/138 • Number of events 4
|
2.1%
3/142 • Number of events 4
|
|
General disorders
Ill-defined disorder
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
General disorders
Localized edema
|
5.8%
8/138 • Number of events 9
|
2.8%
4/142 • Number of events 7
|
|
General disorders
Pain
|
15.2%
21/138 • Number of events 44
|
19.7%
28/142 • Number of events 46
|
|
General disorders
Visceral edema
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Immune system disorders
Cytokine release syndrome
|
2.9%
4/138 • Number of events 5
|
2.8%
4/142 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
1.4%
2/138 • Number of events 9
|
2.8%
4/142 • Number of events 6
|
|
Immune system disorders
Immune system disorder
|
0.72%
1/138 • Number of events 1
|
2.1%
3/142 • Number of events 8
|
|
Infections and infestations
Anal infection
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Bladder infection
|
2.2%
3/138 • Number of events 3
|
2.1%
3/142 • Number of events 3
|
|
Infections and infestations
Bronchitis
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 2
|
|
Infections and infestations
Gingival infection
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Infection
|
6.5%
9/138 • Number of events 11
|
8.5%
12/142 • Number of events 16
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Nail infection
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Infections and infestations
Otitis externa
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Peripheral nerve infection
|
2.2%
3/138 • Number of events 3
|
0.00%
0/142
|
|
Infections and infestations
Pharyngitis
|
2.2%
3/138 • Number of events 3
|
0.00%
0/142
|
|
Infections and infestations
Pneumonia
|
0.00%
0/138
|
2.8%
4/142 • Number of events 5
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
4.3%
6/138 • Number of events 9
|
7.0%
10/142 • Number of events 11
|
|
Infections and infestations
Skin infection
|
5.1%
7/138 • Number of events 10
|
2.1%
3/142 • Number of events 4
|
|
Infections and infestations
Tooth infection
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Infections and infestations
Upper respiratory infection
|
10.1%
14/138 • Number of events 18
|
9.2%
13/142 • Number of events 14
|
|
Infections and infestations
Urinary tract infection
|
2.9%
4/138 • Number of events 5
|
4.9%
7/142 • Number of events 7
|
|
Infections and infestations
Vaginal infection
|
1.4%
2/138 • Number of events 2
|
2.1%
3/142 • Number of events 5
|
|
Infections and infestations
Wound infection
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Injury, poisoning and procedural complications
Aortic injury
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
1.4%
2/138 • Number of events 3
|
2.1%
3/142 • Number of events 10
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.8%
8/138 • Number of events 9
|
6.3%
9/142 • Number of events 9
|
|
Injury, poisoning and procedural complications
Fracture
|
0.72%
1/138 • Number of events 6
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Intraoperative breast injury
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pharyngeal anastomotic leak
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
2.2%
3/138 • Number of events 4
|
2.8%
4/142 • Number of events 4
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/138
|
4.2%
6/142 • Number of events 6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.2%
3/138 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.9%
4/138 • Number of events 4
|
2.8%
4/142 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
19.6%
27/138 • Number of events 104
|
24.6%
35/142 • Number of events 87
|
|
Investigations
Alkaline phosphatase increased
|
10.1%
14/138 • Number of events 44
|
8.5%
12/142 • Number of events 41
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
26/138 • Number of events 77
|
19.7%
28/142 • Number of events 78
|
|
Investigations
Bilirubin increased
|
0.00%
0/138
|
2.1%
3/142 • Number of events 4
|
|
Investigations
Creatinine increased
|
1.4%
2/138 • Number of events 2
|
2.1%
3/142 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
2/138 • Number of events 5
|
1.4%
2/142 • Number of events 10
|
|
Investigations
Laboratory test abnormal
|
2.2%
3/138 • Number of events 8
|
4.9%
7/142 • Number of events 22
|
|
Investigations
Leukocyte count decreased
|
27.5%
38/138 • Number of events 129
|
24.6%
35/142 • Number of events 149
|
|
Investigations
Lymphocyte count decreased
|
15.9%
22/138 • Number of events 99
|
14.8%
21/142 • Number of events 103
|
|
Investigations
Neutrophil count decreased
|
50.7%
70/138 • Number of events 147
|
52.8%
75/142 • Number of events 202
|
|
Investigations
Platelet count decreased
|
4.3%
6/138 • Number of events 6
|
9.2%
13/142 • Number of events 30
|
|
Investigations
Weight gain
|
7.2%
10/138 • Number of events 20
|
9.9%
14/142 • Number of events 39
|
|
Investigations
Weight loss
|
6.5%
9/138 • Number of events 17
|
5.6%
8/142 • Number of events 21
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Metabolism and nutrition disorders
Anorexia
|
19.6%
27/138 • Number of events 71
|
19.0%
27/142 • Number of events 78
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
4/138 • Number of events 5
|
4.2%
6/142 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.2%
3/138 • Number of events 14
|
2.8%
4/142 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.6%
16/138 • Number of events 52
|
15.5%
22/142 • Number of events 89
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.72%
1/138 • Number of events 1
|
3.5%
5/142 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.2%
3/138 • Number of events 3
|
6.3%
9/142 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.1%
14/138 • Number of events 33
|
10.6%
15/142 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.1%
7/138 • Number of events 9
|
4.9%
7/142 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/138
|
4.2%
6/142 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
13/138 • Number of events 21
|
14.8%
21/142 • Number of events 30
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
8.0%
11/138 • Number of events 23
|
11.3%
16/142 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
10.9%
15/138 • Number of events 17
|
9.9%
14/142 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Fibrosis
|
2.2%
3/138 • Number of events 5
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
2.2%
3/138 • Number of events 5
|
2.1%
3/142 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
27.5%
38/138 • Number of events 69
|
31.7%
45/142 • Number of events 103
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.6%
5/138 • Number of events 6
|
5.6%
8/142 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal deformity
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.4%
2/138 • Number of events 4
|
2.8%
4/142 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.3%
39/138 • Number of events 107
|
33.8%
48/142 • Number of events 132
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.8%
8/138 • Number of events 8
|
3.5%
5/142 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck soft tissue necrosis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.72%
1/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
23/138 • Number of events 36
|
12.7%
18/142 • Number of events 34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
2.2%
3/138 • Number of events 3
|
0.70%
1/142 • Number of events 2
|
|
Nervous system disorders
Cognitive disturbance
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
16.7%
23/138 • Number of events 34
|
16.2%
23/142 • Number of events 35
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/138
|
0.70%
1/142 • Number of events 2
|
|
Nervous system disorders
Headache
|
29.0%
40/138 • Number of events 72
|
26.8%
38/142 • Number of events 79
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/138
|
0.70%
1/142 • Number of events 3
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/138
|
0.70%
1/142 • Number of events 3
|
|
Nervous system disorders
Memory impairment
|
5.1%
7/138 • Number of events 13
|
3.5%
5/142 • Number of events 5
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/138
|
1.4%
2/142 • Number of events 3
|
|
Nervous system disorders
Neurological disorder NOS
|
1.4%
2/138 • Number of events 4
|
4.2%
6/142 • Number of events 10
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.0%
11/138 • Number of events 22
|
10.6%
15/142 • Number of events 31
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
92/138 • Number of events 352
|
73.2%
104/142 • Number of events 436
|
|
Nervous system disorders
Seizure
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.72%
1/138 • Number of events 3
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
7.2%
10/138 • Number of events 37
|
14.1%
20/142 • Number of events 62
|
|
Nervous system disorders
Tremor
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
3.6%
5/138 • Number of events 6
|
1.4%
2/142 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
10.9%
15/138 • Number of events 62
|
16.2%
23/142 • Number of events 60
|
|
Psychiatric disorders
Confusion
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 1
|
|
Psychiatric disorders
Depression
|
10.9%
15/138 • Number of events 42
|
13.4%
19/142 • Number of events 50
|
|
Psychiatric disorders
Insomnia
|
21.7%
30/138 • Number of events 73
|
30.3%
43/142 • Number of events 76
|
|
Psychiatric disorders
Libido decreased
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 6
|
|
Psychiatric disorders
Psychosis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Renal and urinary disorders
Cystitis
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Renal and urinary disorders
Kidney pain
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Renal and urinary disorders
Proteinuria
|
1.4%
2/138 • Number of events 2
|
0.00%
0/142
|
|
Renal and urinary disorders
Urinary frequency
|
0.72%
1/138 • Number of events 1
|
2.8%
4/142 • Number of events 4
|
|
Renal and urinary disorders
Urinary incontinence
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 6
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
2/138 • Number of events 2
|
0.70%
1/142 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
1.4%
2/138 • Number of events 2
|
2.1%
3/142 • Number of events 4
|
|
Reproductive system and breast disorders
Breast pain
|
20.3%
28/138 • Number of events 38
|
19.7%
28/142 • Number of events 46
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.72%
1/138 • Number of events 1
|
4.2%
6/142 • Number of events 8
|
|
Reproductive system and breast disorders
Lactation disorder
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/138
|
3.5%
5/142 • Number of events 10
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
0.72%
1/138 • Number of events 3
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.4%
2/138 • Number of events 2
|
2.8%
4/142 • Number of events 5
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.9%
4/138 • Number of events 7
|
2.8%
4/142 • Number of events 7
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/138
|
2.1%
3/142 • Number of events 3
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal mucositis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.5%
9/138 • Number of events 9
|
11.3%
16/142 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/138
|
1.4%
2/142 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hemorrhage
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/138
|
1.4%
2/142 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.9%
4/138 • Number of events 6
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
27/138 • Number of events 54
|
14.8%
21/142 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.4%
24/138 • Number of events 40
|
17.6%
25/142 • Number of events 50
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
5.8%
8/138 • Number of events 13
|
9.2%
13/142 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.72%
1/138 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.1%
7/138 • Number of events 9
|
9.2%
13/142 • Number of events 24
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.6%
5/138 • Number of events 8
|
6.3%
9/142 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/138
|
2.1%
3/142 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/138
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
8.0%
11/138 • Number of events 23
|
7.0%
10/142 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.2%
3/138 • Number of events 6
|
1.4%
2/142 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
67.4%
93/138 • Number of events 588
|
69.0%
98/142 • Number of events 579
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.4%
2/138 • Number of events 2
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.1%
7/138 • Number of events 11
|
2.8%
4/142 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.8%
8/138 • Number of events 11
|
3.5%
5/142 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
12.3%
17/138 • Number of events 26
|
10.6%
15/142 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
23.9%
33/138 • Number of events 71
|
29.6%
42/142 • Number of events 93
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.9%
4/138 • Number of events 7
|
4.2%
6/142 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.72%
1/138 • Number of events 1
|
0.00%
0/142
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
11/138 • Number of events 16
|
9.9%
14/142 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.9%
15/138 • Number of events 21
|
11.3%
16/142 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.4%
24/138 • Number of events 42
|
28.2%
40/142 • Number of events 59
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
8.7%
12/138 • Number of events 22
|
6.3%
9/142 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.5%
9/138 • Number of events 24
|
17.6%
25/142 • Number of events 60
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.72%
1/138 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.1%
7/138 • Number of events 10
|
4.9%
7/142 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Vascular disorders
Flushing
|
1.4%
2/138 • Number of events 5
|
5.6%
8/142 • Number of events 10
|
|
Vascular disorders
Hemorrhage
|
1.4%
2/138 • Number of events 2
|
2.8%
4/142 • Number of events 6
|
|
Vascular disorders
Hot flashes
|
29.0%
40/138 • Number of events 101
|
31.7%
45/142 • Number of events 101
|
|
Vascular disorders
Hypertension
|
18.1%
25/138 • Number of events 100
|
16.9%
24/142 • Number of events 83
|
|
Vascular disorders
Hypotension
|
2.2%
3/138 • Number of events 6
|
4.2%
6/142 • Number of events 10
|
|
Vascular disorders
Peripheral ischemia
|
0.72%
1/138 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Vascular disorders
Phlebitis
|
1.4%
2/138 • Number of events 3
|
0.00%
0/142
|
|
Vascular disorders
Thrombosis
|
2.9%
4/138 • Number of events 5
|
3.5%
5/142 • Number of events 5
|
Additional Information
Aman U. Buzdar, MD
University of Texas MD Anderson Cancer Center, Houston, TX, USA
Phone: 713-792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60