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	over 18		POA-74285

Objectives

I.  Compare in a randomized Phase III trial the response rate and duration of 
response produced by standard-dose vs. high-dose megestrol acetate in patients 
with advanced breast cancer who have failed tamoxifen or other first-line 
hormonal therapy.
II.  Evaluate the toxicity associated with high-dose megestrol acetate 
administration in such patients.
III.  Determine the response rate, duration of response, and toxicity of 
high-dose megestrol acetate in patients who have failed low-dose therapy on 
this protocol.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients over the age of 18 years 
with histologically confirmed progressive metastatic breast cancer provided 
they have failed one previous trial of hormonal therapy, whether ablative, 
additive, or antiestrogen, and that they have not previously received 
progestin therapy.  Concurrent progestin therapy for nonmalignant disease is 
not allowed.  Patients may have been treated with up to 3 prior chemotherapy 
regimens.  Measurable or evaluable disease is required.  ER or PR status must 
be positive or both unknown; however, patients who are negative for either are 
eligible provided they had a documented CR or PR to only one previous course 
of hormonal therapy.  The performance status must be 0-3.  There may be no 
prior malignancy except for nonmelanomatous skin cancer, cancer of the cervix 
treated more than 3 years prior to entry without evidence of recurrence, and 
cancer of any type with no evidence of recurrence for greater than 5 years.  
Radiotherapy may have been administered within 1 month if there is measurable 
or evaluable disease outside the irradiation portal, and concomitant 
irradiation of disease other than indicator lesions will be allowed.  Patients 
with CNS metastases as the sole evidence of disease are excluded.

Expected Enrollment

If there are no responses among the first 15 patients on either arm or not 
more than 2 responses in the first 30, the study will be suspended.  
Otherwise, accrual will continue with analysis after each 30 patients (15 
patients on each arm) are treated.  A maximum of 150 patients will be entered 
over about 2.5 years.  An initial sample of 25 patients who cross over from 
low- to high-dose therapy will be studied for response.  If no responses are 
observed in these first 25 patients, the cross-over arm will be closed; if one 
or more responses occur, accrual will continue until 50 patients cross over or 
the protocol is closed, whichever occurs first.

Outline

Randomized study.
Arm I:  Single-agent Endocrine Therapy.  Megestrol acetate, MEG, NSC-71423.  
Standard dose.
Arm II:  Single-agent Endocrine Therapy.  MEG.  High dose.

Trial Contact Information

Trial Lead Organizations

Piedmont Oncology Association Regional Cooperative Group

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