Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed no age specified SEG-BRE-81210

Objectives

I.  Determine the therapeutic efficacy, response rate, and response duration 
of patients with metastatic breast carcinoma treated with aclacinomycin.
II.  Determine the frequency and extent of alopecia and the frequency of 
severe cardiotoxicity in these patients.
III.  Determine the effect of extravasation of aclacinomycin on local tissues.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with measurable, metastatic, 
histologically documented adenocarcinoma of the breast that is resistant to 
cyclophosphamide, 5-fluorouracil, and methotrexate who may have received prior 
treatment with vincristine, alkeran, or prednisone, but who have not been 
treated with anthracyclines.  ER-positive tumors must be resistant to hormonal 
manipulation.  There may have been no cytotoxic or hormonal therapy during the 
4 weeks prior to entry, and disease must be clearly progressing.  The 
performance status must be 50 percent or better; liver, kidney, and bone 
marrow function must be adequate.  There may be no second primary cancer.

Expected Enrollment

29 patients will be entered, with an expected accrual time of 1-2 years.  
Protocol closed April 1983.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Aclacinomycin, ACM, NSC-208734.

Gockerman JP, Raney M, Logan T: Phase II evaluation of aclarubicin in advanced breast cancer: a Southeastern Cancer Study Group trial. Cancer Treat Rep 69(9): 1029-1030, 1985.

Trial Contact Information

Trial Lead Organizations

Southeastern Cancer Study Group

George A. Omura, MD, Protocol chair		Ph: 205-444-4617