Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Adjuvant Doxorubicin, Cyclophosphamide, and Docetaxel With or Without Trastuzumab (Herceptin) Versus Trastuzumab, Docetaxel, and Either Carboplatin or Cisplatin in Women Who Have Undergone Surgery For HER2-neu-Expressing Node-Positive or High-Risk Node-Negative Breast Cancer

Basic Trial Information

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. It is not yet known which treatment regimen will be more effective in treating breast cancer.

Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have undergone surgery for breast cancer.

Eligibility:

• 18-70 years old
• No bilateral breast cancer
• No previous biological therapy, chemotherapy, hormone therapy, or radiation therapy for breast cancer
• No more than 2 months since surgery for breast cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of three groups. Patients in each group will receive different regimens of combination chemotherapy with or without trastuzumab. Treatment may be repeated every 3 weeks for up to six courses. Patients may continue to receive trastuzumab for approximately 1 year. Beginning 3-4 weeks after completing chemotherapy, some patients will receive tamoxifen by mouth once a day for 5 years. Beginning 3-8 weeks after completing chemotherapy, some patients may undergo radiation therapy. Quality of life will be assessed periodically. Patients will be evaluated at 1 month, every 3 months for 2 years, every 6 months for 3 years, and once a year for 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Sanofi-Aventis France

Linnea Chap, MD, Principal investigator		Ph: 310-206-6144; 888-798-0719

Registry Information
Official Title		Multicenter Phase III Randomized Trial Comparing Doxorubicin And Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin And Cyclophosphamide Followed By Docetaxel And Tastuzumab (AC-TH) And With Docetaxel, Platinum Salt And Trastuzumab (TCH) In The Treatment Of Node Positive And High Risk Node Negative Adjuvant Patients With Operable Breast Cancer Containing The HER2NEU Alteration
Trial Start Date		2001-09-10
Registered in ClinicalTrials.gov		NCT00768092
Date Submitted to PDQ		2001-05-24
Information Last Verified		2004-05-18
NCI Grant/Contract Number		CA16042

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