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Trial record 78 of 78 for:    sanofi-aventis and sweden

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

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: NCT00021255
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Herceptin
Drug: Carboplatin
Enrollment 3222
Recruitment Details The study was conducted at 433 centers in 43 countries. A total of 3222 participants randomized between 05 April 2001 and 30 March 2004. Participants stratified according to institution, nodal status(negative, positive 1-3 nodes, positive 4 or more nodes) and hormonal receptor status (estrogen and/or progesterone receptor positive versus negative).
Pre-assignment Details Participants were randomized in 1:1:1 ratio to receive adjuvant therapy with either AC→ T, AC→ TH or TCH. During the course of the study, some participants received treatment different from the arm in which they were randomized. The safety analyses was conducted as per the treatment received.
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Hide Arm/Group Description Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Period Title: Overall Study
Started 1073 [1] 1074 [1] 1075 [1]
Treated 1045 1072 1057
Safety Population 1018 [2] 1100 [3] 1056 [4]
Completed 952 804 926
Not Completed 121 270 149
Reason Not Completed
Death             1             0             2
Breast cancer relapse             5             18             11
Second primary malignancy             0             4             1
Withdrawal by Subject             41             64             26
Lost to Follow-up             0             2             3
Cardiac toxicity             0             61             32
Herceptin toxicity             0             22             6
Adverse Event             46             30             18
Protocol Violation             0             2             0
Other than specified above             0             38             19
Missing             0             27             13
Randomized but not treated             28             2             18
[1]
Randomized
[2]
1018 participants received AC-T (1012 from AC-T arm, 6 from AC-TH arm).
[3]
1100 participants received AC-TH (1066 from AC-TH arm, 33 from AC-T arm and 1 from TCH arm).
[4]
1056 participants received TCH.
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH) Total
Hide Arm/Group Description Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. Total of all reporting groups
Overall Number of Baseline Participants 1073 1074 1075 3222
Hide Baseline Analysis Population Description
Intent-To-Treat (ITT) population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1073 participants 1074 participants 1075 participants 3222 participants
48.8  (9.7) 48.7  (9.7) 48.6  (9.9) 48.7  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1073 participants 1074 participants 1075 participants 3222 participants
Female
1073
 100.0%
1074
 100.0%
1075
 100.0%
3222
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Disease Free Survival at 5 Years
Hide Description Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Time Frame From randomization until relapse or death or up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Hide Arm/Group Description:
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Overall Number of Participants Analyzed 1073 1074 1075
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.5
(72.8 to 78.2)
83.2
(80.9 to 85.4)
81.0
(78.6 to 83.4)
2.Secondary Outcome
Title Percentage of Participants With Disease Free Survival at 10 Years
Hide Description Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
Time Frame From randomization until relapse or death or up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Hide Arm/Group Description:
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Overall Number of Participants Analyzed 1073 1074 1075
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.2
(64.2 to 70.2)
73.4
(70.6 to 76.2)
72.3
(69.4 to 75.1)
3.Secondary Outcome
Title Overall Survival- Percentage of Participants Who Survived at 10 Years
Hide Description Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.
Time Frame From randomization until death or up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Hide Arm/Group Description:
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
Overall Number of Participants Analyzed 1073 1074 1075
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of particpants
78.9
(76.2 to 81.5)
86.0
(83.8 to 88.2)
83.4
(81.0 to 85.8)
Time Frame All Adverse Events (AE) were collected from the time the participant started treatment with study drug until 30 days after the last infusion of study treatment (chemotherapy or Herceptin).
Adverse Event Reporting Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'on treatment period' (from the first infusion of study drug until 30 days after the last infusion of study drug). Safety population included all treated participants. Source vocabulary used to define AE term: Pooled NCI-CTC version 2.0 and COSTART version 5.0
 
Arm/Group Title Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Hide Arm/Group Description Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
All-Cause Mortality
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   218/1018 (21.41%)   298/1100 (27.09%)   283/1056 (26.80%) 
Blood and lymphatic system disorders       
ANEMIA  1  1/1018 (0.10%)  8/1100 (0.73%)  9/1056 (0.85%) 
LEUKOPENIA  1  21/1018 (2.06%)  23/1100 (2.09%)  20/1056 (1.89%) 
LYMPHEDEMA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
PANCYTOPENIA  1  1/1018 (0.10%)  1/1100 (0.09%)  2/1056 (0.19%) 
THROMBOCYTOPENIA  1  0/1018 (0.00%)  1/1100 (0.09%)  3/1056 (0.28%) 
Cardiac disorders       
ANGINA PECTORIS  1  0/1018 (0.00%)  1/1100 (0.09%)  1/1056 (0.09%) 
AORTIC STENOSIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ARRHYTHMIA  1  2/1018 (0.20%)  3/1100 (0.27%)  3/1056 (0.28%) 
ARTERIAL ANOMALY  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
AV BLOCK  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
CARDIOMYOPATHY  1  0/1018 (0.00%)  2/1100 (0.18%)  1/1056 (0.09%) 
CARDIOVASCULAR DISORDER  1  2/1018 (0.20%)  0/1100 (0.00%)  0/1056 (0.00%) 
CAROTID OCCLUSION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
CEREBROVASCULAR ACCIDENT  1  0/1018 (0.00%)  1/1100 (0.09%)  3/1056 (0.28%) 
DEEP THROMBOPHLEBITIS  1  6/1018 (0.59%)  13/1100 (1.18%)  15/1056 (1.42%) 
ELECTROCARDIOGRAM ABNORMAL  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
HEART ARREST  1  0/1018 (0.00%)  2/1100 (0.18%)  1/1056 (0.09%) 
HEART FAILURE  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
HEMORRHAGE  1  0/1018 (0.00%)  2/1100 (0.18%)  2/1056 (0.19%) 
HYPERTENSION  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
HYPOTENSION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
LEFT HEART FAILURE  1  8/1018 (0.79%)  25/1100 (2.27%)  2/1056 (0.19%) 
MYOCARDIAL ISCHEMIA  1  0/1018 (0.00%)  5/1100 (0.45%)  4/1056 (0.38%) 
MYOCARDITIS  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
PALPITATION  1  0/1018 (0.00%)  3/1100 (0.27%)  1/1056 (0.09%) 
PERICARDIAL EFFUSION  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
PHLEBITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
POSTURAL HYPOTENSION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
SYNCOPE  1  1/1018 (0.10%)  4/1100 (0.36%)  1/1056 (0.09%) 
TACHYCARDIA  1  2/1018 (0.20%)  0/1100 (0.00%)  2/1056 (0.19%) 
VASCULITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
VENTRICULAR ARRHYTHMIA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
Endocrine disorders       
THYROID DISORDER  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
Gastrointestinal disorders       
ANOREXIA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
CHOLECYSTITIS  1  2/1018 (0.20%)  0/1100 (0.00%)  1/1056 (0.09%) 
CHOLELITHIASIS  1  0/1018 (0.00%)  2/1100 (0.18%)  1/1056 (0.09%) 
COLITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  4/1056 (0.38%) 
CONSTIPATION  1  1/1018 (0.10%)  0/1100 (0.00%)  1/1056 (0.09%) 
DIARRHEA  1  2/1018 (0.20%)  10/1100 (0.91%)  11/1056 (1.04%) 
DYSPHAGIA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ESOPHAGITIS  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
GASTRITIS  1  1/1018 (0.10%)  1/1100 (0.09%)  0/1056 (0.00%) 
GASTROENTERITIS  1  1/1018 (0.10%)  2/1100 (0.18%)  3/1056 (0.28%) 
GASTROINTESTINAL HEMORRHAGE  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
HEMATEMESIS  1  0/1018 (0.00%)  1/1100 (0.09%)  1/1056 (0.09%) 
INTESTINAL PERFORATION  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
MELENA  1  1/1018 (0.10%)  1/1100 (0.09%)  0/1056 (0.00%) 
NAUSEA  1  3/1018 (0.29%)  7/1100 (0.64%)  3/1056 (0.28%) 
PERFORATED STOMACH ULCER  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
PROCTITIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
RECTAL HEMORRHAGE  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
STOMACH ULCER  1  0/1018 (0.00%)  0/1100 (0.00%)  2/1056 (0.19%) 
STOMATITIS  1  7/1018 (0.69%)  4/1100 (0.36%)  1/1056 (0.09%) 
VOMITING  1  12/1018 (1.18%)  16/1100 (1.45%)  11/1056 (1.04%) 
General disorders       
ABDOMINAL PAIN  1  2/1018 (0.20%)  3/1100 (0.27%)  2/1056 (0.19%) 
ABSCESS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ACCIDENTAL INJURY  1  0/1018 (0.00%)  3/1100 (0.27%)  3/1056 (0.28%) 
AGGRAVATION REACTION  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ALLERGIC REACTION  1  2/1018 (0.20%)  7/1100 (0.64%)  5/1056 (0.47%) 
ASTHENIA  1  4/1018 (0.39%)  3/1100 (0.27%)  6/1056 (0.57%) 
BACK PAIN  1  1/1018 (0.10%)  3/1100 (0.27%)  0/1056 (0.00%) 
CELLULITIS  1  7/1018 (0.69%)  7/1100 (0.64%)  11/1056 (1.04%) 
CHEST PAIN  1  5/1018 (0.49%)  7/1100 (0.64%)  6/1056 (0.57%) 
CHILLS  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
CYST  1  0/1018 (0.00%)  0/1100 (0.00%)  4/1056 (0.38%) 
FEVER  1  85/1018 (8.35%)  109/1100 (9.91%)  86/1056 (8.14%) 
HEADACHE  1  1/1018 (0.10%)  0/1100 (0.00%)  1/1056 (0.09%) 
HYPOTHERMIA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
IMMUNE SYSTEM DISORDER  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
INFECTION  1  68/1018 (6.68%)  85/1100 (7.73%)  85/1056 (8.05%) 
INJECTION SITE PAIN  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
MUCOUS MEMBRANE DISORDER  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
PAIN  1  1/1018 (0.10%)  1/1100 (0.09%)  0/1056 (0.00%) 
PERITONITIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
PHOTOSENSITIVITY REACTION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
RADIATION INJURY  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
REACTION UNEVALUABLE  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
SEPSIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
DEAFNESS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
EAR PAIN  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
OTITIS MEDIA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
VESTIBULAR DISORDER  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
Metabolism and nutrition disorders       
ACIDOSIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
DEHYDRATION  1  1/1018 (0.10%)  5/1100 (0.45%)  5/1056 (0.47%) 
EDEMA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ENZYMATIC ABNORMALITY  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
GENERALIZED EDEMA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
HYPERGLYCEMIA  1  1/1018 (0.10%)  0/1100 (0.00%)  1/1056 (0.09%) 
HYPOKALEMIA  1  0/1018 (0.00%)  0/1100 (0.00%)  2/1056 (0.19%) 
HYPOMAGNESEMIA  1  0/1018 (0.00%)  0/1100 (0.00%)  3/1056 (0.28%) 
HYPONATREMIA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
HYPOVOLEMIA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
PERIPHERAL EDEMA  1  1/1018 (0.10%)  1/1100 (0.09%)  1/1056 (0.09%) 
SGOT INCREASED  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/1018 (0.10%)  1/1100 (0.09%)  1/1056 (0.09%) 
ARTHRITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
BONE PAIN  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
JOINT DISORDER  1  0/1018 (0.00%)  1/1100 (0.09%)  1/1056 (0.09%) 
MYALGIA  1  1/1018 (0.10%)  1/1100 (0.09%)  1/1056 (0.09%) 
Nervous system disorders       
ANXIETY  1  1/1018 (0.10%)  1/1100 (0.09%)  0/1056 (0.00%) 
CEREBRAL INFARCT  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
COMA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
CONFUSION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
CONVULSION  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
DEPRESSION  1  0/1018 (0.00%)  5/1100 (0.45%)  3/1056 (0.28%) 
DIZZINESS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
EMOTIONAL LABILITY  1  0/1018 (0.00%)  2/1100 (0.18%)  0/1056 (0.00%) 
GRAND MAL CONVULSION  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
MENINGITIS  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
NEUROPATHY  1  3/1018 (0.29%)  3/1100 (0.27%)  4/1056 (0.38%) 
TRISMUS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
VERTIGO  1  0/1018 (0.00%)  0/1100 (0.00%)  2/1056 (0.19%) 
Renal and urinary disorders       
BREAST NEOPLASM  1  0/1018 (0.00%)  1/1100 (0.09%)  1/1056 (0.09%) 
CYSTITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
ENDOMETRIAL CARCINOMA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
ENDOMETRIAL DISORDER  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
HEMATURIA  1  0/1018 (0.00%)  0/1100 (0.00%)  2/1056 (0.19%) 
KIDNEY FAILURE  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
KIDNEY FUNCTION ABNORMAL  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
MENSTRUAL DISORDER  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
TOXIC NEPHROPATHY  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
URINARY TRACT DISORDER  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
URINARY TRACT INFECTION  1  0/1018 (0.00%)  2/1100 (0.18%)  1/1056 (0.09%) 
VAGINITIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
Respiratory, thoracic and mediastinal disorders       
APNEA  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
ASTHMA  1  0/1018 (0.00%)  1/1100 (0.09%)  2/1056 (0.19%) 
BRONCHIECTASIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
DYSPNEA  1  0/1018 (0.00%)  1/1100 (0.09%)  3/1056 (0.28%) 
LUNG DISORDER  1  0/1018 (0.00%)  2/1100 (0.18%)  0/1056 (0.00%) 
LUNG EDEMA  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
LUNG FIBROSIS  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
PHARYNGITIS  1  1/1018 (0.10%)  0/1100 (0.00%)  2/1056 (0.19%) 
PLEURAL EFFUSION  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
PNEUMONIA  1  4/1018 (0.39%)  4/1100 (0.36%)  3/1056 (0.28%) 
PNEUMOTHORAX  1  0/1018 (0.00%)  3/1100 (0.27%)  0/1056 (0.00%) 
RHINITIS  1  1/1018 (0.10%)  2/1100 (0.18%)  0/1056 (0.00%) 
SINUSITIS  1  0/1018 (0.00%)  1/1100 (0.09%)  1/1056 (0.09%) 
Skin and subcutaneous tissue disorders       
ACNE  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
APPLICATION SITE REACTION  1  1/1018 (0.10%)  1/1100 (0.09%)  0/1056 (0.00%) 
EXFOLIATIVE DERMATITIS  1  3/1018 (0.29%)  1/1100 (0.09%)  0/1056 (0.00%) 
FUNGAL DERMATITIS  1  0/1018 (0.00%)  0/1100 (0.00%)  1/1056 (0.09%) 
MACULOPAPULAR RASH  1  4/1018 (0.39%)  1/1100 (0.09%)  1/1056 (0.09%) 
NAIL DISORDER  1  1/1018 (0.10%)  0/1100 (0.00%)  0/1056 (0.00%) 
RASH  1  0/1018 (0.00%)  0/1100 (0.00%)  3/1056 (0.28%) 
SKIN BENIGN NEOPLASM  1  0/1018 (0.00%)  1/1100 (0.09%)  0/1056 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI V2/COSTART V5
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) AC Followed by Docetaxel + Herceptin (AC→TH) Docetaxel + Carboplatin + Herceptin (TCH)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1017/1018 (99.90%)   1100/1100 (100.00%)   1052/1056 (99.62%) 
Blood and lymphatic system disorders       
LYMPHEDEMA  1  81/1018 (7.96%)  94/1100 (8.55%)  107/1056 (10.13%) 
Cardiac disorders       
HYPERTENSION  1  40/1018 (3.93%)  72/1100 (6.55%)  78/1056 (7.39%) 
LEFT HEART FAILURE  1  30/1018 (2.95%)  71/1100 (6.45%)  31/1056 (2.94%) 
PALPITATION  1  69/1018 (6.78%)  94/1100 (8.55%)  95/1056 (9.00%) 
TACHYCARDIA  1  50/1018 (4.91%)  62/1100 (5.64%)  67/1056 (6.34%) 
Gastrointestinal disorders       
ANOREXIA  1  230/1018 (22.59%)  238/1100 (21.64%)  252/1056 (23.86%) 
CONSTIPATION  1  383/1018 (37.62%)  403/1100 (36.64%)  351/1056 (33.24%) 
DIARRHEA  1  439/1018 (43.12%)  555/1100 (50.45%)  658/1056 (62.31%) 
DYSPEPSIA  1  204/1018 (20.04%)  273/1100 (24.82%)  263/1056 (24.91%) 
NAUSEA  1  890/1018 (87.43%)  967/1100 (87.91%)  863/1056 (81.72%) 
STOMATITIS  1  660/1018 (64.83%)  735/1100 (66.82%)  564/1056 (53.41%) 
VOMITING  1  563/1018 (55.30%)  628/1100 (57.09%)  428/1056 (40.53%) 
General disorders       
ABDOMINAL PAIN  1  179/1018 (17.58%)  220/1100 (20.00%)  240/1056 (22.73%) 
ALLERGIC REACTION  1  100/1018 (9.82%)  137/1100 (12.45%)  153/1056 (14.49%) 
ASTHENIA  1  838/1018 (82.32%)  925/1100 (84.09%)  878/1056 (83.14%) 
BACK PAIN  1  82/1018 (8.06%)  132/1100 (12.00%)  96/1056 (9.09%) 
CHEST PAIN  1  73/1018 (7.17%)  103/1100 (9.36%)  91/1056 (8.62%) 
CHILLS  1  58/1018 (5.70%)  88/1100 (8.00%)  78/1056 (7.39%) 
FEVER  1  162/1018 (15.91%)  206/1100 (18.73%)  145/1056 (13.73%) 
HEADACHE  1  301/1018 (29.57%)  323/1100 (29.36%)  306/1056 (28.98%) 
INFECTION  1  350/1018 (34.38%)  445/1100 (40.45%)  327/1056 (30.97%) 
INJECTION SITE REACTION  1  66/1018 (6.48%)  70/1100 (6.36%)  84/1056 (7.95%) 
PAIN  1  222/1018 (21.81%)  268/1100 (24.36%)  217/1056 (20.55%) 
AMBLYOPIA  1  34/1018 (3.34%)  52/1100 (4.73%)  55/1056 (5.21%) 
CONJUNCTIVITIS  1  111/1018 (10.90%)  122/1100 (11.09%)  45/1056 (4.26%) 
DRY EYES  1  41/1018 (4.03%)  56/1100 (5.09%)  30/1056 (2.84%) 
LACRIMATION DISORDER  1  210/1018 (20.63%)  264/1100 (24.00%)  124/1056 (11.74%) 
TASTE PERVERSION  1  291/1018 (28.59%)  312/1100 (28.36%)  320/1056 (30.30%) 
Metabolism and nutrition disorders       
HYPERGLYCEMIA  1  77/1018 (7.56%)  85/1100 (7.73%)  79/1056 (7.48%) 
PERIPHERAL EDEMA  1  339/1018 (33.30%)  405/1100 (36.82%)  347/1056 (32.86%) 
WEIGHT GAIN  1  197/1018 (19.35%)  262/1100 (23.82%)  254/1056 (24.05%) 
WEIGHT LOSS  1  81/1018 (7.96%)  100/1100 (9.09%)  69/1056 (6.53%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  439/1018 (43.12%)  515/1100 (46.82%)  335/1056 (31.72%) 
BONE PAIN  1  187/1018 (18.37%)  235/1100 (21.36%)  144/1056 (13.64%) 
MYALGIA  1  541/1018 (53.14%)  614/1100 (55.82%)  415/1056 (39.30%) 
Nervous system disorders       
ANXIETY  1  86/1018 (8.45%)  78/1100 (7.09%)  70/1056 (6.63%) 
DEPRESSION  1  106/1018 (10.41%)  139/1100 (12.64%)  119/1056 (11.27%) 
DIZZINESS  1  112/1018 (11.00%)  154/1100 (14.00%)  130/1056 (12.31%) 
DRY MOUTH  1  87/1018 (8.55%)  55/1100 (5.00%)  37/1056 (3.50%) 
EMOTIONAL LABILITY  1  56/1018 (5.50%)  65/1100 (5.91%)  41/1056 (3.88%) 
INSOMNIA  1  226/1018 (22.20%)  288/1100 (26.18%)  252/1056 (23.86%) 
NEUROPATHY  1  514/1018 (50.49%)  569/1100 (51.73%)  406/1056 (38.45%) 
VASODILATATION  1  364/1018 (35.76%)  416/1100 (37.82%)  384/1056 (36.36%) 
Renal and urinary disorders       
BREAST PAIN  1  53/1018 (5.21%)  59/1100 (5.36%)  62/1056 (5.87%) 
DYSURIA  1  24/1018 (2.36%)  51/1100 (4.64%)  58/1056 (5.49%) 
MENSTRUAL DISORDER  1  368/1018 (36.15%)  356/1100 (32.36%)  384/1056 (36.36%) 
Respiratory, thoracic and mediastinal disorders       
COUGH INCREASED  1  187/1018 (18.37%)  205/1100 (18.64%)  147/1056 (13.92%) 
DYSPNEA  1  227/1018 (22.30%)  270/1100 (24.55%)  229/1056 (21.69%) 
EPISTAXIS  1  60/1018 (5.89%)  143/1100 (13.00%)  170/1056 (16.10%) 
PHARYNGITIS  1  74/1018 (7.27%)  94/1100 (8.55%)  60/1056 (5.68%) 
RHINITIS  1  175/1018 (17.19%)  277/1100 (25.18%)  193/1056 (18.28%) 
Skin and subcutaneous tissue disorders       
ALOPECIA  1  1003/1018 (98.53%)  1083/1100 (98.45%)  1018/1056 (96.40%) 
DRY SKIN  1  76/1018 (7.47%)  101/1100 (9.18%)  61/1056 (5.78%) 
EXFOLIATIVE DERMATITIS  1  87/1018 (8.55%)  87/1100 (7.91%)  32/1056 (3.03%) 
MACULOPAPULAR RASH  1  275/1018 (27.01%)  354/1100 (32.18%)  330/1056 (31.25%) 
NAIL DISORDER  1  507/1018 (49.80%)  484/1100 (44.00%)  303/1056 (28.69%) 
PRURITUS  1  38/1018 (3.73%)  50/1100 (4.55%)  66/1056 (6.25%) 
RASH  1  238/1018 (23.38%)  279/1100 (25.36%)  313/1056 (29.64%) 
SKIN DISCOLORATION  1  65/1018 (6.39%)  67/1100 (6.09%)  50/1056 (4.73%) 
SWEATING  1  67/1018 (6.58%)  67/1100 (6.09%)  73/1056 (6.91%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI V2/COSTART V5
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-US@sanofi.com
Publications:
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00021255     History of Changes
Obsolete Identifiers: NCT00768092
Other Study ID Numbers: TAX_GMA_302
BCIRG 006
First Submitted: July 11, 2001
First Posted: January 27, 2003
Results First Submitted: June 15, 2016
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016