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

Alternate Title

Phase III Randomized Study of Doxorubicin and Cyclophosphamide With or Without Dexrazoxane, Followed By Paclitaxel With or Without Trastuzumab (Herceptin), Followed By Surgery and Radiotherapy With or Without Trastuzumab in Women With HER-2+ Stage IIIA or IIIB or Regional Stage IV Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care, Treatment	Completed	18 and over	NCI	CLB-49808 NCT00016276, CALGB-49808

Special Category: CTSU trial

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer.

Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer.

Eligibility:

• At least 18 years old
• Measurable or evaluable disease
• No previous chemotherapy
• No previous sentinel lymph node biopsy
• 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 eight groups. They will receive infusions of combination chemotherapy for up to 22 weeks, and will undergo surgery to remove part or all of the breast, followed by radiation therapy for up to 8 weeks. Patients in some treatment groups will receive dexrazoxane and/or trastuzumab. Treatment may continue for as long as benefit is shown. Some patients will also receive tamoxifen by mouth once a day for up to 5 years. Patients will be evaluated every 6 months for 5 years and then 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

Cancer and Leukemia Group B

Mark Graham, MD, Protocol chair(Contact information may not be current)		Ph: 919-966-4431 Email: gman@med.unc.edu

Registry Information
Official Title		A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Local Therapy Followed By 40 Weeks Of Weekly Trastuzumab Or None In Women With HER-2+ Stage IV Breast Cancer
Trial Start Date		2001-05-01
Registered in ClinicalTrials.gov		NCT00016276
Date Submitted to PDQ		2001-03-21
Information Last Verified		2007-08-02
NCI Grant/Contract Number		CA31946

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