Docetaxel in 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: NCT00312208|
Recruitment Status : Completed
First Posted : April 7, 2006
Results First Posted : February 17, 2010
Last Update Posted : December 30, 2013
Primary objective :
- To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.
Secondary objectives :
- To compare toxicity and quality of life between the 2 above-mentioned arms.
- To evaluate pathologic and molecular markers for predicting efficacy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel, doxorubicin, cyclophosphamide Drug: Docetaxel,doxorubicin, cyclophosphamide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3299 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2013|
Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -> T)
Drug: Docetaxel,doxorubicin, cyclophosphamide
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)
Drug: docetaxel, doxorubicin, cyclophosphamide
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
- Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival) [ Time Frame: Median follow-up 65 months ]The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
- Death From Any Cause (Overall Survival) [ Time Frame: Median follow-up of 65 months ]The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312208
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Buenos Aires, Argentina|
|Macquarie Park, Australia|
|Bosnia and Herzegovina|
|Sarajevo, Bosnia and Herzegovina|
|Sao Paulo, Brazil|
|Praha, Czech Republic|
|Hong Kong, Hong Kong|
|Korea, Republic of|
|Seoul, Korea, Republic of|
|Auckland, New Zealand|
|Porto Salvo, Portugal|
|Moscow, Russian Federation|
|Jeddah, Saudi Arabia|
|Midrand, South Africa|
|Study Director:||Jean-Philippe AUSSEL||Sanofi|