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

Alternate Title

Phase II Study of Cyclophosphamide, Methotrexate, Fluorouracil, and Trastuzumab (Herceptin®) in Women With c-erbB2-Positive Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	EORTC-10995 EORTC-16999, IDBBC-EORTC-10995, NCT00036868

Trial Description

Purpose:

Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and fluorouracil 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 trastuzumab may kill more tumor cells.

Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No CNS metastases
• More than 2 weeks since hormone therapy
• 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 receive cyclophosphamide by mouth on days 1-14 or by infusion on days 1 and 8. They will also receive infusions of methotrexate and fluorouracil on days 1 and 8. Patients also receive a 30- to 90-minute infusion of trastuzumab once during each week of chemotherapy.Treatment may be repeated every 4 weeks for up to eight courses. Patients will then receive trastuzumab alone once every 3 weeks for as long as benefit is shown. Patients will be evaluated every 8-12 weeks.

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

European Organization for Research and Treatment of Cancer

Martine Piccart-Gebhart, MD, PhD, Study coordinator		Ph: 32-2-541-3206 Email: martine.piccart@bordet.be
Pierre Fumoleau, MD, PhD, Study coordinator		Ph: 33-3-8073-7506
Laura Biganzoli, MD, Study coordinator(Contact information may not be current)		Ph: 32-2-541-3501

Registry Information
Official Title		A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody (Herceptin) In Women With c-erbB2 Positive Metastatic Breast Cancer
Trial Start Date		2002-02-05
Registered in ClinicalTrials.gov		NCT00036868
Date Submitted to PDQ		2002-03-11
Information Last Verified		2006-01-05

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