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Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00513292
Recruitment Status : Completed
First Posted : August 8, 2007
Results First Posted : September 29, 2015
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HER2/Neu Positive
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Interventions Drug: Cyclophosphamide
Drug: Epirubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Procedure: Therapeutic Conventional Surgery
Biological: Trastuzumab
Enrollment 280
Recruitment Details Total Enrolled: 282, 2 patients withdrew consent before starting treatment, 280 patients started the treatment and are eligible for primary analysis.
Pre-assignment Details  
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 138 142
Completed 138 142
Not Completed 0 0
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75 Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 138 142 280
Hide Baseline Analysis Population Description
Total enrolled: 282, 2 withdrew consent before start of treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 138 participants 142 participants 280 participants
51
(32 to 76)
48
(28 to 73)
50
(28 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 138 participants 142 participants 280 participants
Female
138
 100.0%
142
 100.0%
280
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 138 participants 142 participants 280 participants
138 142 280
1.Primary Outcome
Title pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
Hide Description 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.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who started study treatment are included in the analysis of the primary endpoint.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 138 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.5
(47.8 to 64.9)
54.2
(45.7 to 62.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FEC-75 Then Paclitaxel/Trastuzumab, Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Comments The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .7
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages between arms
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-9.3 to 13.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 89 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage (95% confidence Interval)
48.3
(37.6 to 59.2)
46.7
(36.4 to 56.9)
3.Secondary Outcome
Title Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
Hide Description The summary of asymptomatic decrease in LVEF.
Time Frame Baseline, at 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 130 137
Measure Type: Number
Unit of Measure: Percentage of participants
no decrease or decrease < 10%, still above LLN 92.3 82.5
decrease < 10%, below lower limit of normal (LLN) 0.8 0
decrease 10-15%, still above lower limit of normal 6.2 11.7
decrease 10-15%, below lower limit of normal (LLN) 0 0
decrease > 15%, still above lower limit of norm 0.8 2.9
decrease > 15%, below lower limit of normal 0 2.9
4.Secondary Outcome
Title Asymptomatic Decreases From Baseline in LVEF at Week 24
Hide Description The summary of asymptomatic changed in LVEF.
Time Frame Baseline, at 24 week
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 126 130
Measure Type: Number
Unit of Measure: Percentage of Participants
no decrease or decrease < 10%, still above LLN 83.3 73.1
decrease < 10%, below lower limit of normal (LLN) 0.8 3.1
decrease 10-15%, still above lower limit of normal 7.9 15.4
decrease 10-15%, below lower limit of normal (LLN) 2.4 0.8
decrease > 15%, still above lower limit of normal 1.6 6.9
decrease > 15%, below lower limit of normal (LLN) 4.0 0.8
5.Secondary Outcome
Title LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week
Hide Description 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. Difference from pretreatment LVEF (%) at 12 weeks [median change from baseline Inter Quartile Range (IQR)].
Time Frame At 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 130 137
Median (Inter-Quartile Range)
Unit of Measure: percent
2
(-5 to 2)
-3
(-7 to 0)
6.Secondary Outcome
Title Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week
Hide Description Difference from pretreatment LVEF (%) at 24 weeks [median change from baseline Inter Quartile Range (IQR)].
Time Frame Baseline, at 24 week
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 126 130
Median (Inter-Quartile Range)
Unit of Measure: percent
-3
(-7 to 0)
-4
(-9 to 0)
7.Secondary Outcome
Title Breast Conservation
Hide Description 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).
Time Frame From time surgery to up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that underwent breast surgery were included in this analysis.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 130 138
Measure Type: Number
Unit of Measure: percentage of participants
37.7 39.1
8.Secondary Outcome
Title Disease-free Survival (DFS)
Hide Description 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.
Time Frame From time to registration to time of event, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol therapy are included in this analysis
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 138 142
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Too few events occurred to report a median and 95% Confidence Interval.
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS of Arm I and Arm II patients will be estimated using the Kaplan-Meier method.
Time Frame From time to registration to death, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol therapy were included in this analysis.
Arm/Group Title FEC-75 Then Paclitaxel/Trastuzumab Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 138 142
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Too few events occurred to report a median and 95% Confidence Interval.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A Arm B
Hide Arm/Group Description 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 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
All-Cause Mortality
Arm A Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/138 (13.77%)      26/142 (18.31%)    
Blood and lymphatic system disorders     
Blood disorder  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Febrile neutropenia  1  1/138 (0.72%)  1 3/142 (2.11%)  4
Hemoglobin decreased  1  8/138 (5.80%)  12 11/142 (7.75%)  14
Hemolysis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Cardiac disorders     
Atrial fibrillation  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Left ventricular failure  1  3/138 (2.17%)  3 5/142 (3.52%)  6
Myocardial ischemia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Sinus tachycardia  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Supraventricular tachycardia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Eye disorders     
Extraocular muscle paresis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Eyelid function disorder  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Vision blurred  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/138 (1.45%)  3 3/142 (2.11%)  3
Anal pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Colonic hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Constipation  1  4/138 (2.90%)  4 4/142 (2.82%)  4
Diarrhea  1  9/138 (6.52%)  12 8/142 (5.63%)  8
Dyspepsia  1  1/138 (0.72%)  1 2/142 (1.41%)  3
Dysphagia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Ear, nose and throat examination abnormal  1  4/138 (2.90%)  6 0/142 (0.00%)  0
Gastritis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Gastrointestinal disorder  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Ileus  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Nausea  1  10/138 (7.25%)  11 8/142 (5.63%)  10
Rectal hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Stomach pain  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Vomiting  1  5/138 (3.62%)  5 6/142 (4.23%)  6
General disorders     
Chest pain  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Chills  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Edema limbs  1  3/138 (2.17%)  3 4/142 (2.82%)  4
Fatigue  1  13/138 (9.42%)  23 17/142 (11.97%)  23
Fever  1  6/138 (4.35%)  7 4/142 (2.82%)  4
Localized edema  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Pain  1  1/138 (0.72%)  2 1/142 (0.70%)  1
Immune system disorders     
Cytokine release syndrome  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Infections and infestations     
Bladder infection  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Bronchitis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Infection  1  2/138 (1.45%)  2 3/142 (2.11%)  4
Peripheral nerve infection  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pharyngitis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pneumonia  1  2/138 (1.45%)  2 4/142 (2.82%)  4
Skin infection  1  5/138 (3.62%)  5 2/142 (1.41%)  2
Soft tissue infection  1  1/138 (0.72%)  2 0/142 (0.00%)  0
Upper respiratory infection  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Urinary tract infection  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Wound infection  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Injury, poisoning and procedural complications     
Dermatitis radiation  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Fracture  1  1/138 (0.72%)  2 2/142 (1.41%)  2
Thermal burn  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Vascular access complication  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  4/138 (2.90%)  7 2/142 (1.41%)  2
Alkaline phosphatase increased  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Aspartate aminotransferase increased  1  2/138 (1.45%)  4 3/142 (2.11%)  3
Creatinine increased  1  1/138 (0.72%)  1 0/142 (0.00%)  0
INR increased  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Laboratory test abnormal  1  2/138 (1.45%)  2 1/142 (0.70%)  2
Leukocyte count decreased  1  3/138 (2.17%)  3 8/142 (5.63%)  12
Lymphocyte count decreased  1  1/138 (0.72%)  3 6/142 (4.23%)  11
Neutrophil count decreased  1  6/138 (4.35%)  7 13/142 (9.15%)  20
Platelet count decreased  1  1/138 (0.72%)  1 3/142 (2.11%)  3
Serum cholesterol increased  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Weight gain  1  0/138 (0.00%)  0 3/142 (2.11%)  3
Weight loss  1  3/138 (2.17%)  4 2/142 (1.41%)  2
Metabolism and nutrition disorders     
Alkalosis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Anorexia  1  3/138 (2.17%)  4 6/142 (4.23%)  6
Dehydration  1  3/138 (2.17%)  4 2/142 (1.41%)  2
Hyperglycemia  1  1/138 (0.72%)  1 3/142 (2.11%)  3
Hyperkalemia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Hypernatremia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Hypoalbuminemia  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Hypocalcemia  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Hypoglycemia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Hypokalemia  1  1/138 (0.72%)  2 3/142 (2.11%)  3
Hyponatremia  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Musculoskeletal and connective tissue disorders     
Back pain  1  2/138 (1.45%)  4 0/142 (0.00%)  0
Bone pain  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Chest wall pain  1  1/138 (0.72%)  1 2/142 (1.41%)  4
Joint pain  1  3/138 (2.17%)  3 3/142 (2.11%)  3
Muscle weakness  1  1/138 (0.72%)  2 1/142 (0.70%)  2
Muscle weakness lower limb  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Musculoskeletal disorder  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Myalgia  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Neck pain  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Pain in extremity  1  2/138 (1.45%)  2 1/142 (0.70%)  4
Nervous system disorders     
Dizziness  1  2/138 (1.45%)  2 3/142 (2.11%)  3
Encephalopathy  1  1/138 (0.72%)  2 0/142 (0.00%)  0
Headache  1  6/138 (4.35%)  7 9/142 (6.34%)  10
Neurological disorder NOS  1  1/138 (0.72%)  9 0/142 (0.00%)  0
Peripheral motor neuropathy  1  1/138 (0.72%)  1 1/142 (0.70%)  2
Peripheral sensory neuropathy  1  5/138 (3.62%)  6 8/142 (5.63%)  10
Syncope  1  2/138 (1.45%)  2 2/142 (1.41%)  2
Taste alteration  1  1/138 (0.72%)  4 1/142 (0.70%)  2
Tremor  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Psychiatric disorders     
Agitation  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Anxiety  1  2/138 (1.45%)  4 2/142 (1.41%)  2
Confusion  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Depression  1  2/138 (1.45%)  4 7/142 (4.93%)  8
Insomnia  1  1/138 (0.72%)  3 5/142 (3.52%)  5
Reproductive system and breast disorders     
Breast pain  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Irregular menstruation  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Bronchopulmonary hemorrhage  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Bronchospasm  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Cough  1  3/138 (2.17%)  3 4/142 (2.82%)  4
Dyspnea  1  7/138 (5.07%)  7 7/142 (4.93%)  7
Hemorrhage nasal  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Pharyngolaryngeal pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pneumonitis  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Respiratory disorder  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Voice alteration  1  1/138 (0.72%)  3 1/142 (0.70%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  9/138 (6.52%)  13 11/142 (7.75%)  14
Hand-and-foot syndrome  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Nail disorder  1  4/138 (2.90%)  4 1/142 (0.70%)  1
Pain of skin  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Rash acneiform  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Rash desquamating  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Skin disorder  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Skin hyperpigmentation  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Skin ulceration  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Sweating  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Vascular disorders     
Hematoma  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Hemorrhage  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Hot flashes  1  2/138 (1.45%)  3 2/142 (1.41%)  2
Hypertension  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Hypotension  1  2/138 (1.45%)  2 1/142 (0.70%)  2
Thrombosis  1  1/138 (0.72%)  1 3/142 (2.11%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   136/138 (98.55%)      141/142 (99.30%)    
Blood and lymphatic system disorders     
Blood disorder  1  3/138 (2.17%)  6 5/142 (3.52%)  7
Febrile neutropenia  1  2/138 (1.45%)  3 3/142 (2.11%)  3
Hemoglobin decreased  1  53/138 (38.41%)  279 50/142 (35.21%)  269
Hemolysis  1  0/138 (0.00%)  0 2/142 (1.41%)  8
Lymph node pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Lymphatic disorder  1  0/138 (0.00%)  0 2/142 (1.41%)  5
Thrombotic microangiopathy  1  2/138 (1.45%)  2 5/142 (3.52%)  8
Cardiac disorders     
Arrhythmia  1  3/138 (2.17%)  4 1/142 (0.70%)  1
Cardiac disorder  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Left ventricular dysfunction  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Left ventricular failure  1  9/138 (6.52%)  14 18/142 (12.68%)  25
Myocardial ischemia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Palpitations  1  5/138 (3.62%)  7 4/142 (2.82%)  4
Pericardial effusion  1  1/138 (0.72%)  1 3/142 (2.11%)  4
Premature ventricular contractions  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Sinus arrhythmia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Sinus bradycardia  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Sinus tachycardia  1  9/138 (6.52%)  12 8/142 (5.63%)  14
Supraventricular tachycardia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Ventricular arrhythmia  1  1/138 (0.72%)  1 2/142 (1.41%)  14
Ventricular tachycardia  1  0/138 (0.00%)  0 1/142 (0.70%)  9
Ear and labyrinth disorders     
Ear disorder  1  1/138 (0.72%)  3 2/142 (1.41%)  2
Ear pain  1  0/138 (0.00%)  0 2/142 (1.41%)  2
External ear inflammation  1  1/138 (0.72%)  1 0/142 (0.00%)  0
External ear pain  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Hearing loss  1  0/138 (0.00%)  0 1/142 (0.70%)  2
Middle ear inflammation  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Tinnitus  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Endocrine disorders     
Hypothyroidism  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Eye disorders     
Conjunctival disorder  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Dry eye syndrome  1  2/138 (1.45%)  3 3/142 (2.11%)  5
Extraocular muscle paresis  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Eye disorder  1  1/138 (0.72%)  5 9/142 (6.34%)  17
Eye pain  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Eyelid function disorder  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Vision blurred  1  11/138 (7.97%)  14 16/142 (11.27%)  37
Watering eyes  1  2/138 (1.45%)  4 3/142 (2.11%)  9
Gastrointestinal disorders     
Abdominal distension  1  2/138 (1.45%)  2 4/142 (2.82%)  9
Abdominal pain  1  9/138 (6.52%)  12 16/142 (11.27%)  24
Anal hemorrhage  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Anal mucositis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Colitis  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Constipation  1  57/138 (41.30%)  142 51/142 (35.92%)  113
Diarrhea  1  72/138 (52.17%)  172 79/142 (55.63%)  210
Dry mouth  1  1/138 (0.72%)  1 3/142 (2.11%)  3
Dyspepsia  1  16/138 (11.59%)  48 24/142 (16.90%)  52
Dysphagia  1  4/138 (2.90%)  5 6/142 (4.23%)  9
Ear, nose and throat examination abnormal  1  46/138 (33.33%)  86 41/142 (28.87%)  78
Endoscopy large bowel abnormal  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Enteritis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Esophageal mucositis  1  2/138 (1.45%)  4 1/142 (0.70%)  1
Esophagitis  1  1/138 (0.72%)  2 0/142 (0.00%)  0
Flatulence  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Gastric mucositis  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Gastritis  1  3/138 (2.17%)  3 8/142 (5.63%)  10
Gastrointestinal disorder  1  3/138 (2.17%)  4 9/142 (6.34%)  10
Gingival pain  1  0/138 (0.00%)  0 3/142 (2.11%)  3
Hemorrhoids  1  3/138 (2.17%)  6 7/142 (4.93%)  9
Ileus  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Mucositis oral  1  21/138 (15.22%)  31 17/142 (11.97%)  31
Nausea  1  101/138 (73.19%)  325 108/142 (76.06%)  315
Oral hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Oral pain  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Pancreatitis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Proctitis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Rectal hemorrhage  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Salivary gland disorder  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Stomach pain  1  2/138 (1.45%)  2 5/142 (3.52%)  5
Tooth disorder  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Toothache  1  0/138 (0.00%)  0 4/142 (2.82%)  4
Vomiting  1  54/138 (39.13%)  98 46/142 (32.39%)  89
General disorders     
Chest pain  1  5/138 (3.62%)  5 9/142 (6.34%)  12
Chills  1  8/138 (5.80%)  14 7/142 (4.93%)  12
Edema limbs  1  28/138 (20.29%)  47 29/142 (20.42%)  85
Fatigue  1  124/138 (89.86%)  768 126/142 (88.73%)  711
Fever  1  10/138 (7.25%)  11 21/142 (14.79%)  28
Flu-like symptoms  1  2/138 (1.45%)  2 2/142 (1.41%)  2
General symptom  1  3/138 (2.17%)  4 3/142 (2.11%)  4
Ill-defined disorder  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Localized edema  1  8/138 (5.80%)  9 4/142 (2.82%)  7
Pain  1  21/138 (15.22%)  44 28/142 (19.72%)  46
Visceral edema  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Immune system disorders     
Cytokine release syndrome  1  4/138 (2.90%)  5 4/142 (2.82%)  6
Hypersensitivity  1  2/138 (1.45%)  9 4/142 (2.82%)  6
Immune system disorder  1  1/138 (0.72%)  1 3/142 (2.11%)  8
Infections and infestations     
Anal infection  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Bladder infection  1  3/138 (2.17%)  3 3/142 (2.11%)  3
Bronchitis  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Catheter related infection  1  1/138 (0.72%)  1 1/142 (0.70%)  2
Gingival infection  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Infection  1  9/138 (6.52%)  11 12/142 (8.45%)  16
Infectious colitis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Laryngitis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Nail infection  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Otitis externa  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Peripheral nerve infection  1  3/138 (2.17%)  3 0/142 (0.00%)  0
Pharyngitis  1  3/138 (2.17%)  3 0/142 (0.00%)  0
Pneumonia  1  0/138 (0.00%)  0 4/142 (2.82%)  5
Rhinitis infective  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Sepsis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Sinusitis  1  6/138 (4.35%)  9 10/142 (7.04%)  11
Skin infection  1  7/138 (5.07%)  10 3/142 (2.11%)  4
Tooth infection  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Upper respiratory infection  1  14/138 (10.14%)  18 13/142 (9.15%)  14
Urinary tract infection  1  4/138 (2.90%)  5 7/142 (4.93%)  7
Vaginal infection  1  2/138 (1.45%)  2 3/142 (2.11%)  5
Wound infection  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Injury, poisoning and procedural complications     
Aortic injury  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Bruising  1  2/138 (1.45%)  3 3/142 (2.11%)  10
Dermatitis radiation  1  8/138 (5.80%)  9 9/142 (6.34%)  9
Fracture  1  1/138 (0.72%)  6 1/142 (0.70%)  1
Intraoperative breast injury  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pharyngeal anastomotic leak  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Radiation recall reaction (dermatologic)  1  3/138 (2.17%)  4 4/142 (2.82%)  4
Seroma  1  0/138 (0.00%)  0 6/142 (4.23%)  6
Thermal burn  1  2/138 (1.45%)  2 1/142 (0.70%)  2
Vascular access complication  1  3/138 (2.17%)  4 1/142 (0.70%)  1
Wound dehiscence  1  4/138 (2.90%)  4 4/142 (2.82%)  4
Investigations     
Alanine aminotransferase increased  1  27/138 (19.57%)  104 35/142 (24.65%)  87
Alkaline phosphatase increased  1  14/138 (10.14%)  44 12/142 (8.45%)  41
Aspartate aminotransferase increased  1  26/138 (18.84%)  77 28/142 (19.72%)  78
Bilirubin increased  1  0/138 (0.00%)  0 3/142 (2.11%)  4
Creatinine increased  1  2/138 (1.45%)  2 3/142 (2.11%)  5
Gamma-glutamyltransferase increased  1  2/138 (1.45%)  5 2/142 (1.41%)  10
Laboratory test abnormal  1  3/138 (2.17%)  8 7/142 (4.93%)  22
Leukocyte count decreased  1  38/138 (27.54%)  129 35/142 (24.65%)  149
Lymphocyte count decreased  1  22/138 (15.94%)  99 21/142 (14.79%)  103
Neutrophil count decreased  1  70/138 (50.72%)  147 75/142 (52.82%)  202
Platelet count decreased  1  6/138 (4.35%)  6 13/142 (9.15%)  30
Weight gain  1  10/138 (7.25%)  20 14/142 (9.86%)  39
Weight loss  1  9/138 (6.52%)  17 8/142 (5.63%)  21
Metabolism and nutrition disorders     
Alkalosis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Anorexia  1  27/138 (19.57%)  71 27/142 (19.01%)  78
Dehydration  1  4/138 (2.90%)  5 6/142 (4.23%)  6
Hypercalcemia  1  3/138 (2.17%)  14 4/142 (2.82%)  4
Hyperglycemia  1  16/138 (11.59%)  52 22/142 (15.49%)  89
Hyperkalemia  1  1/138 (0.72%)  1 5/142 (3.52%)  5
Hypertriglyceridemia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Hypoalbuminemia  1  2/138 (1.45%)  2 1/142 (0.70%)  3
Hypocalcemia  1  3/138 (2.17%)  3 9/142 (6.34%)  12
Hypoglycemia  1  0/138 (0.00%)  0 1/142 (0.70%)  2
Hypokalemia  1  14/138 (10.14%)  33 15/142 (10.56%)  32
Hypomagnesemia  1  1/138 (0.72%)  1 2/142 (1.41%)  6
Hyponatremia  1  7/138 (5.07%)  9 7/142 (4.93%)  14
Hypophosphatemia  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/138 (0.00%)  0 6/142 (4.23%)  11
Back pain  1  13/138 (9.42%)  21 21/142 (14.79%)  30
Bone pain  1  11/138 (7.97%)  23 16/142 (11.27%)  22
Chest wall pain  1  15/138 (10.87%)  17 14/142 (9.86%)  19
Fibrosis  1  3/138 (2.17%)  5 1/142 (0.70%)  1
Joint disorder  1  3/138 (2.17%)  5 3/142 (2.11%)  3
Joint effusion  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Joint pain  1  38/138 (27.54%)  69 45/142 (31.69%)  103
Muscle weakness  1  5/138 (3.62%)  6 8/142 (5.63%)  8
Muscle weakness lower limb  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Muscle weakness upper limb  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Musculoskeletal deformity  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Musculoskeletal disorder  1  2/138 (1.45%)  4 4/142 (2.82%)  4
Myalgia  1  39/138 (28.26%)  107 48/142 (33.80%)  132
Myositis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Neck pain  1  8/138 (5.80%)  8 5/142 (3.52%)  5
Neck soft tissue necrosis  1  0/138 (0.00%)  0 1/142 (0.70%)  3
Osteoporosis  1  1/138 (0.72%)  2 1/142 (0.70%)  1
Pain in extremity  1  23/138 (16.67%)  36 18/142 (12.68%)  34
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Nervous system disorders     
Ataxia  1  3/138 (2.17%)  3 1/142 (0.70%)  2
Cognitive disturbance  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Dizziness  1  23/138 (16.67%)  34 23/142 (16.20%)  35
Facial nerve disorder  1  0/138 (0.00%)  0 1/142 (0.70%)  2
Headache  1  40/138 (28.99%)  72 38/142 (26.76%)  79
Hypoglossal nerve disorder  1  0/138 (0.00%)  0 1/142 (0.70%)  3
Intracranial hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Leukoencephalopathy  1  0/138 (0.00%)  0 1/142 (0.70%)  3
Memory impairment  1  7/138 (5.07%)  13 5/142 (3.52%)  5
Mini mental status examination abnormal  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Neuralgia  1  0/138 (0.00%)  0 2/142 (1.41%)  3
Neurological disorder NOS  1  2/138 (1.45%)  4 6/142 (4.23%)  10
Olfactory nerve disorder  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Peripheral motor neuropathy  1  11/138 (7.97%)  22 15/142 (10.56%)  31
Peripheral sensory neuropathy  1  92/138 (66.67%)  352 104/142 (73.24%)  436
Seizure  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Sinus pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Syncope  1  1/138 (0.72%)  3 1/142 (0.70%)  1
Taste alteration  1  10/138 (7.25%)  37 20/142 (14.08%)  62
Tremor  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Psychiatric disorders     
Agitation  1  5/138 (3.62%)  6 2/142 (1.41%)  2
Anxiety  1  15/138 (10.87%)  62 23/142 (16.20%)  60
Confusion  1  2/138 (1.45%)  2 1/142 (0.70%)  1
Depression  1  15/138 (10.87%)  42 19/142 (13.38%)  50
Insomnia  1  30/138 (21.74%)  73 43/142 (30.28%)  76
Libido decreased  1  1/138 (0.72%)  1 1/142 (0.70%)  6
Psychosis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Renal and urinary disorders     
Bladder pain  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Cystitis  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Hemoglobinuria  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Hemorrhage urinary tract  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Kidney pain  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Proteinuria  1  2/138 (1.45%)  2 0/142 (0.00%)  0
Urinary frequency  1  1/138 (0.72%)  1 4/142 (2.82%)  4
Urinary incontinence  1  1/138 (0.72%)  1 2/142 (1.41%)  6
Urinary retention  1  2/138 (1.45%)  2 1/142 (0.70%)  2
Urine discoloration  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Urogenital disorder  1  2/138 (1.45%)  2 3/142 (2.11%)  4
Reproductive system and breast disorders     
Breast pain  1  28/138 (20.29%)  38 28/142 (19.72%)  46
Irregular menstruation  1  1/138 (0.72%)  1 6/142 (4.23%)  8
Lactation disorder  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Ovulation pain  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pelvic pain  1  0/138 (0.00%)  0 5/142 (3.52%)  10
Reproductive tract disorder  1  1/138 (0.72%)  3 0/142 (0.00%)  0
Uterine hemorrhage  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Vaginal discharge  1  2/138 (1.45%)  2 4/142 (2.82%)  5
Vaginal dryness  1  4/138 (2.90%)  7 4/142 (2.82%)  7
Vaginal hemorrhage  1  0/138 (0.00%)  0 3/142 (2.11%)  3
Vaginal inflammation  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Vaginal mucositis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Vaginal pain  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  9/138 (6.52%)  9 16/142 (11.27%)  23
Atelectasis  1  0/138 (0.00%)  0 2/142 (1.41%)  2
Bronchial hemorrhage  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Bronchopulmonary hemorrhage  1  0/138 (0.00%)  0 2/142 (1.41%)  3
Bronchospasm  1  4/138 (2.90%)  6 0/142 (0.00%)  0
Cough  1  27/138 (19.57%)  54 21/142 (14.79%)  40
Dyspnea  1  24/138 (17.39%)  40 25/142 (17.61%)  50
Hemorrhage nasal  1  8/138 (5.80%)  13 13/142 (9.15%)  21
Hiccough  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Laryngeal edema  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Laryngeal mucositis  1  1/138 (0.72%)  4 1/142 (0.70%)  1
Nasal congestion  1  7/138 (5.07%)  9 13/142 (9.15%)  24
Pharyngeal mucositis  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Pharyngolaryngeal pain  1  5/138 (3.62%)  8 9/142 (6.34%)  11
Pleural effusion  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Pneumonitis  1  0/138 (0.00%)  0 3/142 (2.11%)  3
Pulmonary fibrosis  1  0/138 (0.00%)  0 1/142 (0.70%)  1
Pulmonary hemorrhage  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Respiratory disorder  1  11/138 (7.97%)  23 10/142 (7.04%)  11
Voice alteration  1  3/138 (2.17%)  6 2/142 (1.41%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  93/138 (67.39%)  588 98/142 (69.01%)  579
Decubitus ulcer  1  2/138 (1.45%)  2 2/142 (1.41%)  2
Dry skin  1  7/138 (5.07%)  11 4/142 (2.82%)  6
Erythema multiforme  1  8/138 (5.80%)  11 5/142 (3.52%)  6
Hand-and-foot syndrome  1  17/138 (12.32%)  26 15/142 (10.56%)  28
Nail disorder  1  33/138 (23.91%)  71 42/142 (29.58%)  93
Pain of skin  1  4/138 (2.90%)  7 6/142 (4.23%)  7
Photosensitivity  1  1/138 (0.72%)  1 0/142 (0.00%)  0
Pruritus  1  11/138 (7.97%)  16 14/142 (9.86%)  14
Rash acneiform  1  15/138 (10.87%)  21 16/142 (11.27%)  29
Rash desquamating  1  24/138 (17.39%)  42 40/142 (28.17%)  59
Scalp pain  1  1/138 (0.72%)  1 1/142 (0.70%)  6
Skin disorder  1  12/138 (8.70%)  22 9/142 (6.34%)  15
Skin hyperpigmentation  1  9/138 (6.52%)  24 25/142 (17.61%)  60
Skin hypopigmentation  1  1/138 (0.72%)  1 2/142 (1.41%)  5
Skin induration  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Skin ulceration  1  1/138 (0.72%)  1 2/142 (1.41%)  2
Sweating  1  7/138 (5.07%)  10 7/142 (4.93%)  13
Urticaria  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Vascular disorders     
Flushing  1  2/138 (1.45%)  5 8/142 (5.63%)  10
Hemorrhage  1  2/138 (1.45%)  2 4/142 (2.82%)  6
Hot flashes  1  40/138 (28.99%)  101 45/142 (31.69%)  101
Hypertension  1  25/138 (18.12%)  100 24/142 (16.90%)  83
Hypotension  1  3/138 (2.17%)  6 6/142 (4.23%)  10
Peripheral ischemia  1  1/138 (0.72%)  1 1/142 (0.70%)  1
Phlebitis  1  2/138 (1.45%)  3 0/142 (0.00%)  0
Thrombosis  1  4/138 (2.90%)  5 5/142 (3.52%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aman U. Buzdar, MD
Organization: University of Texas MD Anderson Cancer Center, Houston, TX, USA
Phone: 713-792-2817
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00513292     History of Changes
Other Study ID Numbers: NCI-2009-00341
NCI-2009-00341 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000559039
ACOSOG-Z1041
Z1041 ( Other Identifier: American College of Surgeons Oncology Group )
ACOSOG-Z1041 ( Other Identifier: CTEP )
U10CA012027 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2007
First Posted: August 8, 2007
Results First Submitted: July 14, 2015
Results First Posted: September 29, 2015
Last Update Posted: January 23, 2019