Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

Study Overview
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Brief Summary
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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 may kill more tumor cells. It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor.

Detailed Description
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OBJECTIVES: Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin. Compare the quality of life in a subgroup of these patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses. Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses. Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment. Patients are followed annually for 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.

Official Title
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National Breast Cancer Study of Epirubicin + CMF v Classical CMF Adjuvant Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: CMF regimen
* Drug: cyclophosphamide
* Drug: epirubicin hydrochloride
* Drug: fluorouracil
* Drug: methotrexate
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histological confirmation of invasive, early stage breast cancer Prior complete excision of tumor required (wide local excision or mastectomy) Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Pre-, peri-, or post-menopausal Performance status: Not specified Hematopoietic: Adequate bone marrow function Hepatic: Adequate hepatic function Renal: Adequate renal function Other: No prior cancer except for basal cell carcinoma or carcinoma in situ Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Concurrent hormone therapy allowed Radiotherapy: No prior radiotherapy Concurrent radiotherapy allowed Surgery: See Disease Characteristics No more than 6 weeks since prior surgery to the breast
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CMF regimen|nan|
|Drug: cyclophosphamide|nan|
|Drug: epirubicin hydrochloride|nan|
|Drug: fluorouracil|nan|
|Drug: methotrexate|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage I breast cancer