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	Treatment	Completed	postmenopausal	NCI	SWOG-8312

Objectives

I.  Compare, in a Phase III study, the response rates, duration of response, 
and overall survival of postmenopausal women with disseminated breast cancer 
who progressed after responding to tamoxifen (or after maintaining stable 
disease for at least 6 months, per Amendment 2, April 1985) in response to 
treatment with megestrol acetate vs. aminoglutethimide/hydrocortisone vs. 
megestrol acetate plus aminoglutethimide/hydrocortisone.
II.  Assess the relative toxicities of megestrol acetate and medical 
adrenalectomy.
III.  Assess the value of progesterone receptor status in predicting 
subsequent responses to a variety of hormonal therapies.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Postmenopausal women with 
progressive, measurable metastatic breast carcinoma who have relapsed after at 
least a partial response to an adequate trial (12 weeks in the absence of 
frank progression) of tamoxifen (e.g., SWOG-8228).  Patients must have either 
undergone physiological menopause at least 1 year prior to entry or have been 
previously castrated surgically for reasons unrelated to breast cancer; the 
latter patients must have postmenopausal levels of FSH and LH.  Patients must 
be ER-positive but may be of any progesterone receptor status (positive, 
negative, unknown; either positive or negative per September 1985 revision).  
Patients may have had prior adjuvant chemotherapy but may not have received 
prior treatment with megestrol or aminoglutethimide.  Patients with 
life-threatening progressive disease in the brain, liver, or lung after 
response to tamoxifen are ineligible if it is felt that chemotherapy would 
result in a more rapid and beneficial response.  Brain or extensive liver 
metastases exclude.  Per Amendment 2, April 1985, patients who maintained 
stable disease for a minimum of 6 months after an adequate trial of tamoxifen 
are eligible.  Per July 1985 revision, references to an "adequate trial" of 
tamoxifen have been deleted.  Per September 1985 revision, patients with 
clear-cut bone scan evidence of cortical bone metastases only are eligible.

Expected Enrollment

A minimum of 246 evaluable patients will be required, with an anticipated 
accrual rate of 6 patients/month.

Outline

Randomized study.
Arm I:  Progestin Therapy.  Megestrol acetate, MEG, NSC-71423.
Arm II:  Medical Adrenalectomy plus Replacement Therapy.  Aminoglutethimide, 
AGT; plus Hydrocortisone, HC, NSC-10483.
Arm III:  Progestin Therapy plus Medical Adrenalectomy and Replacement 
Therapy.  MEG; plus AGT; HC.

Russell CA, Green SJ, O'Sullivan J, et al.: Megestrol acetate and aminoglutethimide/hydrocortisone in sequence or in combination as second-line endocrine therapy of estrogen receptor-positive metastatic breast cancer: a Southwest Oncology Group phase III trial. J Clin Oncol 15 (7): 2494-501, 1997.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

James Congdon, DO, Protocol chair		Ph: 425-258-9388 Email: jcongdon@wwmedgroup.com