Combination Chemotherapy in Treating Women With Stage III Breast Cancer

NCT ID: NCT00002696

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-10-31

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 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.

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

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

CAF regimen

Intervention Type: DRUG

CMF regimen

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Grupo Oncologico Cooperativo del Sur

OTHER

Sponsor Role: lead

Principal Investigators

Bernardo A. Leone, MD

Role: STUDY_CHAIR

Unidad Oncologica Del Neuquen

Locations

Policlinica Privada Instituto De Medicina Nuclear

Bahía Blanca, Buenos Aires, Argentina

Consultorio Oncologico Privado

Mar del Plata, Buenos Aires, Argentina

Centro De Oncologia y Terapia Radiante

Santa Rosa, La Pampa Province, Argentina

Unidad Oncologica Del Comahue

Neuquén, Neuquén Province, Argentina

Consultorio Oncologico Privado

Río Gallegos, , Argentina

Centro Oncologico Del Litoral

Santa Fe, , Argentina

Centro Oncologico Tres Arroyos

Tres Arroyos, , Argentina

Countries

Argentina

Other Identifiers

CDR0000064471

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-F95-0036

Identifier Type: -

Identifier Source: secondary_id

GOCS-08-BR-95-III

Identifier Type: -

Identifier Source: org_study_id