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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		POA-74183 WFU-74183, NCI-V83-0355

Objectives

I.  Determine the response rate and duration of remission of single-agent 
therapy with megestrol acetate vs. tamoxifen in postmenopausal women with 
advanced breast cancer who have positive estrogen receptor (ER) and either 
positive or negative progesterone receptor (PgR) status.
II.  Determine the crossover response of postmenopausal women with advanced 
breast cancer (and positive ER and either positive or negative PgR status) who 
progress on either megestrol acetate or tamoxifen and subsequently receive the 
alternate therapy.
III.  Monitor the side effects and patterns of toxicity of single-agent 
therapy with megestrol acetate vs. tamoxifen.
IV.  Determine the efficacy of single-agent therapy with megestrol acetate in 
postmenopausal women with advanced breast cancer who have negative ER and 
either positive or negative PgR status.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
Stage IV breast cancer.  Patients must be postmenopausal with either a 
physiologic menopause at least 1 year prior to entry or surgical castration 
(bilateral oophorectomy) 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; androgen and glucocorticoid 
receptor status will also be determined for any patient who has a tumor biopsy 
at the time of entry.  Disease must be measurable; for bone sites to be 
considered measurable, disease must be osteolytic or mixed sclerotic/lytic.  
Patients with quiescent disease (i.e., no evidence of progression within 6 
months prior to entry) are ineligible.  The Karnofsky performance status must 
be at least 50%, and patients must have recovered from all toxicity and side 
effects of prior therapy.  At least 6 weeks must have elapsed since prior 
hormonal therapy.  Patients who have received prior treatment with 
progestational or antiestrogenic agents for breast cancer, either as adjuvant 
therapy or as therapy for metastatic disease, are ineligible; prior adjuvant 
chemotherapy including prednisone or other glucocorticoids is allowed.  
Patients who failed to respond to prior hormonal or ablative therapy for 
breast cancer are ineligible.  There may be no brain metastases or CNS lesions 
that require immediate therapy or that are the only evident metastases.  
Thrombophlebitis, thromboembolic disorder, stroke, or a history of these 
conditions excludes.  There may be no evidence of other primary cancer, except 
for superficial nonmelanomatous skin cancer or carcinoma in situ of the 
cervix.  Patients with other existing conditions for which hormonal therapy is 
contraindicated or deemed inappropriate by the investigator (e.g., liver 
involvement of greater than 25%, lymphangitic pulmonary disease, or 
inflammatory breast carcinoma) or for which other therapy (radiotherapy or 
chemotherapy) is deemed more appropriate, are ineligible.  Pregnancy excludes.

Expected Enrollment

A minimum of 400 evaluable patients will be entered.  175 ER-positive patients 
will be randomized to each arm for a total of 350 patients; 50 ER-negative 
patients will be accrued.  Protocol closed October 1984.

Outline

Partially randomized study.  Patients with positive ER status and either 
positive or negative PgR status are randomized to Arms I and II; those with 
negative ER status and either positive or negative PgR 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.

Kuss J, Muss H, Hoen H, et al.: Tamoxifen (Tam) as initial endocrine therapy for advanced breast cancer (ABC): long term follow-up. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-87, 71, 1993.

Trial Contact Information

Trial Lead Organizations

Piedmont Oncology Association Regional Cooperative Group

Hyman Muss, MD, Protocol chair		Ph: 802-656-5487; 800-358-1144