- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002696
Combination Chemotherapy in Treating Women With Stage III Breast Cancer
MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
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.
Study Overview
Status
Conditions
Detailed Description
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
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Neuquen, Argentina
- Unidad Oncologica Del Comahue
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Rio Gallegos, Argentina, 9400
- Consultorio Oncologico Privado
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Santa Fe, Argentina, 3000
- Centro Oncologico Del Litoral
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Tres Arroyos, Argentina, 7500
- Centro Oncologico Tres Arroyos
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Buenos Aires
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Bahia Blanca, Buenos Aires, Argentina, 8000
- Policlínica Privada Instituto de Medicina Nuclear
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Mar del Plata, Buenos Aires, Argentina, 7600
- Consultorio Oncologico Privado
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La Pampa
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Santa Rosa, La Pampa, Argentina, 6300
- Centro De Oncologia y Terapia Radiante
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Investigators
- Study Chair: Bernardo A. Leone, MD, Unidad Oncologica del Neuquen
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Cyclophosphamide
- Fluorouracil
- Doxorubicin
- Liposomal doxorubicin
- Methotrexate
Other Study ID Numbers
- GOCS-08-BR-95-III
- CDR0000064471 (Registry Identifier: PDQ (Physician Data Query))
- NCI-F95-0036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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