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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		NEDH-D-83007 NCI-V85-0130

Objectives

I.  Establish the relative response rate produced by tamoxifen vs. megace vs. 
tamoxifen plus megace in patients with advanced breast cancer.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with advanced breast cancer 
who are estrogen receptor status unknown or who are estrogen receptor positive 
or progesterone receptor positive.  There may have been no prior hormone 
treatment, and patients must have a demonstrable lesion that can be either 
measured or evaluated over time.

Expected Enrollment

Approximately 100 patients will be accrued.

Outline

Randomized study.  Patients are initially randomized to Arms I, II, and III; 
subsequent therapy on Regimen A or B is determined by response and menopausal 
status.
Arm I:  Single-agent Hormonal Therapy.  Tamoxifen, TMX, NSC-180973.
Arm II:  Single-agent Hormonal Therapy.  Megace, Megestrol acetate, MEG, 
NSC-71423.
Arm III:  2-Drug Combination Hormonal Therapy.  TMX; MEG.
Regimen A:  Single-agent Hormonal Therapy.  Aminoglutethimide, AGT.
Regimen B:  2-Drug Combination Hormonal Therapy.  AGT; Ethinyl Estradiol, 
Estinyl, NSC-10973.

Trial Contact Information

Trial Lead Organizations

Beth Israel Deaconess Medical Center

Jacob Lokich, MD, Protocol chair(Contact information may not be current)		Ph: 617-667-4599