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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed no age specified NCI-76-C-377B NCI-MB-160B

Objectives

I.  Compare response rates and duration of responses and proportion of 
complete remissions for two induction regimens for metastatic breast cancer.
II.  Evaluate the ability of hormonal therapy to synchronize tumor cells and 
achieve improved clinical responses, in terms of clinical results and kinetic 
studies in a small proportion of patients with readily biopsied disease.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
documented mammary carcinoma with evidence of measurable progressive disease, 
who have received no cytotoxic therapy except adjuvant melphalan.  Patients 
must have a Karnofsky performance index of at least 30, adequate blood counts, 
and normal liver and kidney function tests, unless abnormalities are due to 
tumor invasion; under any circumstances, patients with a creatinine of greater 
than 2.5 mg% are ineligible.  Patients may not have a history of malignant 
neoplasms aside from curatively treated basal cell or squamous cell carcinoma 
of the skin or surgically cured carcinoma of the cervix in situ.  They may not 
have any medical or psychiatric condition that could contraindicate protocol 
treatment.

Expected Enrollment

Approximately 128 patients will be required.  Protocol closed July 1983.

Outline

Randomized study.  This trial is a revision of NCI-MB-160, and as of July 1979 
patients eligible for NCI-MB-160 enter this study; patients entered prior to 
that date continue treatment on the original protocol, now designated 
NCI-MB-160A.  As of June 1983, patients with Stage IV inflammatory or Stage 
III inoperable breast cancer enter NCI-MB-160C; new patients with metastatic 
breast cancer enter NCI-MB-184.
Arm I:  4-Drug Combination Chemotherapy.  Cyclophosphamide, CTX, NSC-26271; 
Adriamycin, ADR, NSC-123127; Methotrexate, MTX, NSC-740; 5-Fluorouracil, 5-FU, 
NSC-19893.
Arm II:  4-Drug Combination Chemotherapy plus 2-Drug Hormonal Therapy.  CTX; 
ADR; MTX; 5-FU; plus Tamoxifen, TMX, NSC-180973; Premarin, Conjugated 
Estrogens.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Samuel Broder, MD, Protocol chair		Ph: 305-590-2206; 800-327-4114