Combination Chemotherapy in Treating Women With Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002696
Recruitment Status : Suspended
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: CAF regimen Drug: CMF regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: methotrexate Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:


  • 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.


Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : October 1995

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage III breast cancer
  • Measurable disease
  • No inflammatory breast cancer
  • No synchronous bilateral breast cancer
  • Hormone receptor status:

    • Not specified



  • 21 to 75


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1 OR
  • Zubrod 0-1

Life expectancy:

  • More than 12 weeks


  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • AST less than 1.25 times ULN


  • Creatinine clearance greater than 70 mL/min


  • No angina pectoris
  • No significant arrhythmia requiring therapy
  • No bilateral bundle branch block
  • No congestive heart failure
  • No myocardial infarction


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • No prior radiotherapy


  • No prior surgery except incisional biopsy or fine-needle aspiration


  • No prior systemic therapy
  • No concurrent caffeine or alcohol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002696

Policlinica Privada Instituto De Medicina Nuclear
Bahia Blanca, Buenos Aires, Argentina, 8000
Consultorio Oncologico Privado
Mar del Plata, Buenos Aires, Argentina, 7600
Centro De Oncologia y Terapia Radiante
Santa Rosa, La Pampa, Argentina, 6300
Unidad Oncologica Del Comahue
Neuquen, Argentina
Consultorio Oncologico Privado
Rio Gallegos, Argentina, 9400
Centro Oncologico Del Litoral
Santa Fe, Argentina, 3000
Centro Oncologico Tres Arroyos
Tres Arroyos, Argentina, 7500
Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur
Study Chair: Bernardo A. Leone, MD Unidad Oncologica Del Neuquen Identifier: NCT00002696     History of Changes
Other Study ID Numbers: GOCS-08-BR-95-III
CDR0000064471 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Dermatologic Agents
Folic Acid Antagonists