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 III, Phase II Treatment Closed under 65 WCCC-CO-7711R NCI-D80-048-183

Objectives

I.  Evaluate the effect on metastatic breast cancer of intensive combination 
therapy with adriamycin, vincristine, dibromodulcitol, and prednisone followed 
by tamoxifen, fluoxymesterone, bleomycin, hexamethylmelamine, methotrexate, 
and citrovorum factor.  (BLEO reported discontinued December 1981.)
II.  Assess the prognostic importance of selected pretherapy variables such as 
performance status.
As per revision, December 1981, Objectives III and IV have been added.
III.  Ascertain whether the complete remission rate, response duration, and 
survival observed with TMX/FXM/BLEO/MTX-CF is reproducible in the absence of 
bleomycin.
IV.  Ascertain whether Consolidation radiotherapy will alter the biological 
behavior of the disease and provide increased disease control as measured by 
time to treatment failure.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients less than 65 years of age 
with histologically proven, recurrent, measurable, progressive mammary 
carcinoma who have a performance index greater than 40 (Karnofsky) or less 
than 4 (ECOG), adequate hematologic function, and normal renal and hepatic 
function (unless the abnormality is due to metastatic involvement and the 
creatinine is less than 2.5 mg%).  Patients must not have had prior cytotoxic 
therapy, prior malignant neoplasms, and prior adrenalectomy or hypophysectomy. 
 Patients must have had their last menstrual period at least 12 months prior 
to entry or must have demonstrated progressive disease at least 3 weeks after 
oophorectomy.

Expected Enrollment

15 to 40 patients will be entered in 1.5 years.  Protocol closed.

Outline

Nonrandomized study.  As per revision, December 1981, Consolidation 
Radiotherapy has been added.
7-Drug Combination Chemotherapy plus 3-Drug Hormone Therapy.  Adriamycin, ADR, 
NSC-123127 (replaced by Mitomycin-C, MITO, NSC-26980 when the maximum total 
dose has been given); Vincristine, VCR, NSC-67574; Dibromodulcitol, DBD, 
NSC-104800; Bleomycin, BLEO, NSC-125066 (discontinued); Hexamethylmelamine, 
HMM, NSC-13875; Methotrexate, MTX, NSC-740; Citrovorum factor, CF, NSC-3590; 
plus Prednisone, PRED, NSC-10023; Tamoxifen, TMX, NSC-180973; Fluoxymesterone, 
FXM, NSC-12165.
Consolidation:  Radiotherapy.  Irradiation of all or a portion of the on-study 
disease sites.

Tormey DC, Kline JC, Palta M, et al.: Short term high density systemic therapy for metastatic breast cancer. Breast Cancer Res Treat 5 (2): 177-88, 1985.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Paul Carbone, MD, Protocol chair(Contact information may not be current)		Ph: 608-265-8047; 800-622-8922 Email: carbone@biostat.wisc.edu