Combination Chemotherapy in Treating Women With Stage III Breast Cancer

NCT00002696 | Suspended Phase 3

• 3 other identifiers: GOCS-08-BR-95-IIICDR0000064471NCI-F95-0036
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Interventions

CAF regimen DRUG

CMF regimen DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Grupo Oncologico Cooperativo del Sur: lead

Study Sites (7)

Policlinica Privada Instituto De Medicina Nuclear

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Consultorio Oncologico Privado

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Centro De Oncologia y Terapia Radiante

Santa Rosa, La Pampa Province, 6300, Argentina

Location

Unidad Oncologica Del Comahue

Neuquén, Neuquén Province, Argentina

Location

Consultorio Oncologico Privado

Río Gallegos, 9400, Argentina

Location

Centro Oncologico Del Litoral

Santa Fe, 3000, Argentina

Location

Centro Oncologico Tres Arroyos

Tres Arroyos, 7500, Argentina

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CAF protocol; CMF regimen; Cyclophosphamide; Doxorubicin; Fluorouracil; Methotrexate; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Bernardo A. Leone, MD

  Unidad Oncologica Del Neuquen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: October 1, 1995
• Last Updated: August 2, 2013

Record last verified: 2008-04

Locations

AR (7)