Combination Chemotherapy in Treating Women With Stage III Breast Cancer

August 1, 2013 updated by: Grupo Oncologico Cooperativo del Sur

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

Suspended

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Neuquen, Argentina
        • Unidad Oncologica Del Comahue
      • Rio Gallegos, Argentina, 9400
        • Consultorio Oncologico Privado
      • Santa Fe, Argentina, 3000
        • Centro Oncologico Del Litoral
      • Tres Arroyos, Argentina, 7500
        • Centro Oncologico Tres Arroyos
    • Buenos Aires
      • Bahia Blanca, Buenos Aires, Argentina, 8000
        • Policlínica Privada Instituto de Medicina Nuclear
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Consultorio Oncologico Privado
    • La Pampa
      • Santa Rosa, La Pampa, Argentina, 6300
        • Centro De Oncologia y Terapia Radiante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Oncologico Cooperativo del Sur

Investigators

  • Study Chair: Bernardo A. Leone, MD, Unidad Oncologica del Neuquen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1995

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

Subscribe