Combination Chemotherapy in Treating Women With Stage III Breast Cancer

Breast Cancer Clinical Trial

Official title:

MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00002696
• Other study ID #: GOCS-08-BR-95-III
• Secondary ID: CDR0000064471NCI
• Status: Suspended
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: August 1, 2013
• Start date: October 1995

Study information

• Verified date: April 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CAF regimen

• CMF regimen

• cyclophosphamide

• doxorubicin hydrochloride

• fluorouracil

• methotrexate

Procedure:
• adjuvant therapy

• conventional surgery

• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Argentina	Policlinica Privada Instituto De Medicina Nuclear	Bahia Blanca	Buenos Aires
Argentina	Consultorio Oncologico Privado	Mar del Plata	Buenos Aires
Argentina	Unidad Oncologica Del Comahue	Neuquen
Argentina	Consultorio Oncologico Privado	Rio Gallegos
Argentina	Centro Oncologico Del Litoral	Santa Fe
Argentina	Centro De Oncologia y Terapia Radiante	Santa Rosa	La Pampa
Argentina	Centro Oncologico Tres Arroyos	Tres Arroyos

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Oncologico Cooperativo del Sur

Country where clinical trial is conducted

Argentina,