Combination Chemotherapy in Treating Women With Stage III Breast Cancer
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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. Combining more than one drug may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare cyclophosphamide, doxorubicin, and fluorouracil with cyclophosphamide, methotrexate, and fluorouracil in treating women with stage III breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: CAF regimen Drug: CMF regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: methotrexate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER |
| Study Start Date: | October 1995 |
OBJECTIVES:
- Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
- Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
- Compare the disease-free and overall survival of patients treated with these regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the compliance of patients treated with these regimens.
- Assess the cosmetic results in patients treated with conservative surgery.
- 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.
- Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3 courses in the absence of disease progression.
- Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF). Treatment continues every 4 weeks for 3 courses in the absence of disease progression.
Patients on both arms with resectable disease after the third course of chemotherapy undergo quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy, followed by 6 additional courses of chemotherapy on the arm to which they were randomized initially. Those patients without distant metastasis undergo locoregional radiotherapy beginning concurrently with the initiation of postoperative chemotherapy. Patients on both arms with unresectable disease after the initial 3 courses of chemotherapy undergo locoregional radiotherapy and then surgical resection (if feasible).
Quality of life is assessed at baseline and then monthly thereafter.
Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Not specified
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage III breast cancer
- Measurable disease
- No inflammatory breast cancer
- No synchronous bilateral breast cancer
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 21 to 75
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1 OR
- Zubrod 0-1
Life expectancy:
- More than 12 weeks
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.25 times upper limit of normal (ULN)
- AST less than 1.25 times ULN
Renal:
- Creatinine clearance greater than 70 mL/min
Cardiovascular:
- No angina pectoris
- No significant arrhythmia requiring therapy
- No bilateral bundle branch block
- No congestive heart failure
- No myocardial infarction
Other:
- No medical or psychiatric disease that would preclude study therapy
- No other malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- No prior surgery except incisional biopsy or fine-needle aspiration
Other:
- No prior systemic therapy
- No concurrent caffeine or alcohol
Contacts and Locations| Argentina | |
| Policlinica Privada Instituto De Medicina Nuclear | |
| Bahia Blanca, Buenos Aires, Argentina, 8000 | |
| Consultorio Oncologico Privado | |
| Mar del Plata, Buenos Aires, Argentina, 7600 | |
| Centro De Oncologia y Terapia Radiante | |
| Santa Rosa, La Pampa, Argentina, 6300 | |
| Unidad Oncologica Del Comahue | |
| Neuquen, Argentina | |
| Consultorio Oncologico Privado | |
| Rio Gallegos, Argentina, 9400 | |
| Centro Oncologico Del Litoral | |
| Santa Fe, Argentina, 3000 | |
| Centro Oncologico Tres Arroyos | |
| Tres Arroyos, Argentina, 7500 | |
| Study Chair: | Bernardo A. Leone, MD | Unidad Oncologica Del Neuquen |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002696 History of Changes |
| Other Study ID Numbers: | CDR0000064471, GOCS-08-BR-95-III, NCI-F95-0036 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Methotrexate Doxorubicin 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 21, 2013