Combination Chemotherapy in Treating Women With Stage III Breast Cancer

Phase 3

Suspended

• Conditions: Breast Cancer

• Registration Number: NCT00002696
• Lead Sponsor: Grupo Oncologico Cooperativo del Sur

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

Study Timeline

• Study Start: 1995-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2008-04
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Unidad Oncologica Del Comahue; 🇦🇷 Neuquen, Argentina

Centro De Oncologia y Terapia Radiante; 🇦🇷 Santa Rosa, La Pampa, Argentina

Policlinica Privada Instituto De Medicina Nuclear; 🇦🇷 Bahia Blanca, Buenos Aires, Argentina

Centro Oncologico Del Litoral; 🇦🇷 Santa Fe, Argentina

Centro Oncologico Tres Arroyos; 🇦🇷 Tres Arroyos, Argentina

Consultorio Oncologico Privado; 🇦🇷 Rio Gallegos, Argentina