Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in treating women who have early stage breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: CMF regimen Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: fluorouracil Drug: methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer |
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 1996 |
OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant chemotherapy in women with node positive early breast cancer, as measured by overall and event free survival from the date or randomization. II. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4 courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant chemotherapy in these patients, as measured by quality of life.
OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by 4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed, early stage, unilateral invasive breast cancer of TNM stages T0 - T3, N0-1, M0, i.e., Histologically proven axillary node metastases OR Lymph node negative Not locally advanced If supraclavicular node is enlarged or suspicious of metastasis, negative biopsy for supraclavicular node metastases required No evidence of any other metastases clinically or on routine staging investigations No past history of pure in situ carcinoma in either breast Primary tumor is completely excised
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Performance status: Not specified Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 No evidence of sepsis Hepatic: Adequate hepatic function Bilirubin normal AST/ALT normal Renal: Adequate renal function Creatinine less than 1.2 mg/dL Cardiovascular: No clinically significant cardiovascular disease Other: No prior or concurrent other malignancy except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Prior tamoxifen allowed Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Contacts and Locations| United Kingdom | |
| University Hospitals of Leicester | |
| Leicester, England, United Kingdom, LE1 5WW | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Ninewells Hospital and Medical School | |
| Dundee, Scotland, United Kingdom, DD1 9SY | |
| Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 9NQ | |
| University of Glasgow | |
| Glasgow, Scotland, United Kingdom, G61 1BD | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Raigmore Hospital | |
| Inverness, Scotland, United Kingdom, 1V2 3UJ | |
| Royal Alexandra Hospital | |
| Paisley, Scotland, United Kingdom | |
| Ayr Hospital | |
| Ayr, United Kingdom, KA6 6DX | |
| Falkirk Royal Infirmary | |
| Falkirk, United Kingdom, FK1 5RE | |
| Study Chair: | Chris Twelves, MD, BMedSci, FRCP | University of Glasgow |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003012 History of Changes |
| Other Study ID Numbers: | CDR0000065590, SCTN-BR9601, EU-97013 |
| Study First Received: | November 1, 1999 |
| Last Updated: | January 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Methotrexate Epirubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013