Combination Chemotherapy in Treating Women With Resected Breast Cancer

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00033683
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief Summary

RATIONALE: 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.

PURPOSE: 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.

Detailed Description

OBJECTIVES:

* Compare the disease-free and overall survival of women with completely resected stage I or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.

* Compare the acute toxicity of these regimens in these patients.

* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, estrogen receptor status (positive vs negative), and nodal status. Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.

* Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC) IV on day 1. Treatment repeats every 3 weeks for 8 courses.

* Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3 weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF). Treatment with CMF repeats every 4 weeks for 4 courses.

* Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I, regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks for 4 courses.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local practice.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily for at least 5 years.

Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2002-04-09
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2005-06
• Last Update Submitted: 2009-02-06
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (69)

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

North Devon District Hospital; 🇬🇧 Barnstaple, England, United Kingdom

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

Queen Elizabeth Hospital at University of Birmingham; 🇬🇧 Birmingham, England, United Kingdom

City Hospital - Birmingham; 🇬🇧 Birmingham, England, United Kingdom

Blackpool Victoria Hospital; 🇬🇧 Blackpool, England, United Kingdom

Pilgrim Hospital; 🇬🇧 Boston, England, United Kingdom

Bradford Hospitals NHS Trust; 🇬🇧 Bradford, England, United Kingdom

Royal Sussex County Hospital; 🇬🇧 Brighton, England, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

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