Combination Chemotherapy in Treating Women With Stage III Breast Cancer

This study has suspended participant recruitment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002696
First received: November 1, 1999
Last updated: August 1, 2013
Last verified: April 2008
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1995
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

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002696

Locations
Argentina
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
Investigators
Study Chair: Bernardo A. Leone, MD Unidad Oncologica Del Neuquen
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002696     History of Changes
Other Study ID Numbers: GOCS-08-BR-95-III, CDR0000064471, NCI-F95-0036
Study First Received: November 1, 1999
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Fluorouracil
Liposomal doxorubicin
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on October 23, 2014