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	NCI	YALE-HIC-3042 NCI-T83-1271D, T83-1271

Objectives

I.  Determine the response rate and response duration produced by single-agent 
therapy with tamoxifen vs. megestrol acetate in postmenopausal women with 
advanced breast cancer and positive estrogen receptor (ER) status.
II.  Determine the crossover response of postmenopausal women with advanced 
breast cancer and positive ER status who progress on one therapy and 
subsequently receive the alternate therapy.
III.  Determine the efficacy of single-agent therapy with megestrol acetate in 
postmenopausal women with advanced breast cancer having negative ER status and 
either positive or negative progesterone receptor (PgR) status.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Women with measurable advanced, 
recurrent, or metastatic breast cancer.  Patients must be postmenopausal with 
either a physiologic menopause at least one year prior to entry or surgical 
castration at least 12 weeks prior to entry (patients 53 years of age or older 
who have had a hysterectomy with ovaries left intact are considered 
postmenopausal).  ER and PgR determinations must be made from either the 
primary tumor or an area of metastasis.  Prior therapy with progestational or 
antiestrogenic agents for breast cancer (either as adjuvant or active therapy) 
excludes.  There may be no hormonal therapy during the 6 weeks prior to entry; 
patients who have failed on prior hormonal therapy (excluding adjuvant 
chemotherapy including prednisone) are ineligible.  A Karnofsky performance 
status greater than 50% is required, and there may be no history of 
thrombophlebitis, thromboembolic disease, or stroke.  CNS metastases requiring 
immediate therapy or that are the only evidence of metastatic disease exclude. 
 Patients with another malignancy (excluding nonmelanomatous skin cancer or 
carcinoma in situ of the cervix) are ineligible.

Expected Enrollment

175 patients will be randomized to each arm.  The study is expected to require 
3 years.  Protocol closed August 1985.

Outline

Partially randomized study.  Patients with positive ER status are randomized 
to Arms I and II; those with negative ER status are treated on Arm I.
Arm I:  Single-agent Hormonal Therapy.  Megestrol acetate, MEG, NSC-71423.
Arm II:  Single-agent Hormonal Therapy.  Tamoxifen, TMX, NSC-180973.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

John C. Marsh, MD, Protocol chair(Contact information may not be current)		Ph: 203-785-4095; 866-925-3226