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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 Adjuvant Study of Fluorouracil, Epirubicin, and Cyclophosphamide (FEC) or Epirubicin Followed By Cyclophosphamide, Methotrexate, and Fluorouracil (EPI-CMF) Versus FEC Followed By Sequential Docetaxel in Women With Resected Stage I or II Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	Other	ICR-TACT EU-20109, NCT00033683

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known which combination chemotherapy regimen is more effective in treating resected stage I or stage II breast cancer.

Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating women who have resected stage I or stage II breast cancer.

Eligibility:

Eligibility criteria include the following:

• At least 19 years old
• No metastatic cancer
• No more than 8 weeks since surgery for breast cancer
• No previous biological therapy, chemotherapy, or radiation 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 be randomly assigned to one of two groups. Patients in group one will receive one of two combination chemotherapy regimens every 3-4 weeks for up to eight courses. Patients in group two will receive four courses of one of the chemotherapy regimens as in group one followed by infusions of docetaxel once every 3 weeks for four courses. Within 4 weeks after completing chemotherapy, some patients will receive radiation therapy 5 days a week for 3-5 weeks and/or tamoxifen by mouth once a day for at least 5 years. Quality of life will be assessed periodically. Patients will be evaluated every 3 months for 2 years and every 6 months thereafter.

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

Institute of Cancer Research - London

Jane Banerji, Protocol chair		Ph: 44-181-208-7224 Email: jane.banerji@icr.ac.uk

Registry Information
Official Title		A Randomised Trial Of Standard Anthracycline-based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer
Trial Start Date		2001-02-01
Registered in ClinicalTrials.gov		NCT00033683
Date Submitted to PDQ		2002-02-27
Information Last Verified		2005-06-16

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