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

This study has been completed.
Sponsor:
Collaborator:
Cancer International Research Group (CIRG)
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00021255
First received: July 11, 2001
Last updated: September 26, 2016
Last verified: September 2016
Results First Received: June 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Herceptin
Drug: Carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) 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.
AC Followed by Docetaxel + Herceptin (AC→TH) 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.
Docetaxel + Carboplatin + Herceptin (TCH) 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.

Participant Flow:   Overall Study
    Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)   AC Followed by Docetaxel + Herceptin (AC→TH)   Docetaxel + Carboplatin + Herceptin (TCH)
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 
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-To-Treat (ITT) population included all randomized participants.

Reporting Groups
  Description
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T) 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.
AC Followed by Docetaxel + Herceptin (AC→TH) 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.
Docetaxel + Carboplatin + Herceptin (TCH) 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 Total of all reporting groups

Baseline Measures
   Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)   AC Followed by Docetaxel + Herceptin (AC→TH)   Docetaxel + Carboplatin + Herceptin (TCH)   Total 
Overall Participants Analyzed 
[Units: Participants]
 1073   1074   1075   3222 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.8  (9.7)   48.7  (9.7)   48.6  (9.9)   48.7  (9.8) 
Gender 
[Units: Participants]
       
Female   1073   1074   1075   3222 
Male   0   0   0   0 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Disease Free Survival at 5 Years   [ Time Frame: From randomization until relapse or death or up to 5 years ]

2.  Secondary:   Percentage of Participants With Disease Free Survival at 10 Years   [ Time Frame: From randomization until relapse or death or up to 10 years ]

3.  Secondary:   Overall Survival- Percentage of Participants Who Survived at 10 Years   [ Time Frame: From randomization until death or up to 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications:


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00021255     History of Changes
Obsolete Identifiers: NCT00768092
Other Study ID Numbers: TAX_GMA_302
BCIRG 006
Study First Received: July 11, 2001
Results First Received: June 15, 2016
Last Updated: September 26, 2016