Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Women With Stage III Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Temporarily closed 21 to 75 Other GOCS-08-BR-95-III NCI-F95-0036, NCT00002696

Objectives

1. Compare the response in women with stage III breast cancer treated with neoadjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide, methotrexate, and fluorouracil (CMF).
2. Compare the rates of conservative surgical resectability and locoregional control in patients treated with these neoadjuvant therapy regimens.
3. Compare the disease-free and overall survival of patients treated with these regimens.
4. Compare the toxic effects of these regimens in these patients.
5. Compare the compliance of patients treated with these regimens.
6. Assess the cosmetic results in patients treated with conservative surgery.
7. Compare the quality of life of patients treated with these regimens.

Entry 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

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

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/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

Not specified

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.

Trial Contact Information

Trial Lead Organizations

Grupo Oncologico Cooperativo del Sur

Bernardo A. Leone, MD, Protocol chair		Ph: 54-299-448-5247 Email: bleone@satlink.com

Registry Information
Official Title		MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER
Trial Start Date		1995-10-01
Registered in ClinicalTrials.gov		NCT00002696
Date Submitted to PDQ		1995-10-01
Information Last Verified		2008-04-25

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