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

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ClinicalTrials.gov Identifier: NCT00021255

Recruitment Status : Completed

First Posted : January 27, 2003

Results First Posted : November 15, 2016

Last Update Posted : November 15, 2016

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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

Participant Flow

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)
Arm/Group Description	Doxorubicin 60 mg/m² intravenous (I...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...
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.

Baseline Characteristics

Arm/Group Title		Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)	AC Followed by Docetaxel + Herceptin (AC→TH)	Docetaxel + Carboplatin + Herceptin (TCH)	Total
Arm/Group Description		Doxorubicin 60 mg/m² IV bolus injec...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Disease Free Survival at 5 Years
Description	Disease Free Survival was defined as the interval from the date of ran...
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

Outcome Measure Data

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)
Arm/Group Description:	Doxorubicin 60 mg/m² IV bolus injec...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...
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
Description	Disease free survival was defined as the interval from the date of ran...
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

Outcome Measure Data

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)
Arm/Group Description:	Doxorubicin 60 mg/m² IV bolus injec...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...
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
Description	Overall survival of the participants was measured from the date of ran...
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

Outcome Measure Data

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)
Arm/Group Description:	Doxorubicin 60 mg/m² IV bolus injec...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...
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)

Adverse Events

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)
Arm/Group Description	Doxorubicin 60 mg/m² IV bolus injec...	Doxorubicin 60 mg/m² IV bolus injec...	Herceptin 4 mg/kg IV infusion on Da...
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	--/--	--/--	--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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:

Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pinter T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bee V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-8. doi: 10.1634/theoncologist.2013-0091. Epub 2013 Jun 28.

Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013 Feb;138(1):99-108. doi: 10.1007/s10549-013-2444-y. Epub 2013 Feb 19.

Press MF, Sauter G, Buyse M, Bernstein L, Guzman R, Santiago A, Villalobos IE, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Bee V, Taupin H, Flom KJ, Tabah-Fisch I, Pauletti G, Lindsay MA, Riva A, Slamon DJ. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol. 2011 Mar 1;29(7):859-67. doi: 10.1200/JCO.2009.27.5644. Epub 2010 Dec 28.

Stern HM, Gardner H, Burzykowski T, Elatre W, O'Brien C, Lackner MR, Pestano GA, Santiago A, Villalobos I, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Nuciforo P, Bee V, Mackey J, Slamon DJ, Press MF. PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res. 2015 May 1;21(9):2065-74. doi: 10.1158/1078-0432.CCR-14-2993. Epub 2015 Feb 3.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.

Layout table for additonal information

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00021255
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

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