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		GUMC-8683 NCI-V83-0295

Objectives

I.  Compare the response rate and duration of response of postmenopausal 
patients with advanced carcinoma of the breast (ER-positive, progesterone 
receptor-positive or receptor-negative) treated with megestrol acetate vs. 
tamoxifen.
II.  Determine the crossover response of those patients who fail either 
treatment.
III.  Compare the side effects and patterns of toxicity of these two 
treatments.
IV.  Evaluate megestrol acetate as single therapy in postmenopausal women with 
advanced breast cancer that is ER-negative, regardless of progesterone 
receptor status.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Postmenopausal patients with 
histologically proven, measurable Stage IV carcinoma of the breast provided 
the ER and progesterone receptor (PgR) status of the primary tumor or a 
metastasis is known and they are not candidates for more appropriate 
treatment.  Patients must be at least 1 year post physiological menopause or 
at least 12 weeks post surgical castration.  Patients aged at least 53 years 
who have had a hysterectomy without oophorectomy are considered menopausal.  
Measurable disease includes osteolytic and mixed sclerotic/lytic disease.  The 
performance status must be at least 50 percent on the Karnofsky scale or 2 or 
better on the ECOG scale, and there must have been full recovery from all 
toxicities associated with previous treatment.  At least 6 weeks shall have 
intervened since previous hormonal therapy, and there may have been no 
previous treatment with progestational or antiestrogenic agents for breast 
cancer, either as adjuvant or active therapy.  Patients may not have failed 
prior hormonal or ablative therapy for breast cancer; prior adjuvant 
chemotherapy, including prednisone or other glucocorticoids, is allowed.  
There may be no evidence of brain metastases or CNS lesions that require 
immediate therapy or that are the sole evidence of metastasis.  Patients may 
not be pregnant, nor may there be any past or present thrombophlebitis, 
thromboembolic disorders, or stroke.  Aside from superficial nonmelanomatous 
skin cancer and carcinoma in situ of the cervix, there may be no second 
primary cancer.  Patients may not have any existing condition for which 
hormonal therapy is contraindicated, nor may there be liver involvement of 
greater than 25 percent, lymphangitic pulmonary disease, or inflammatory 
breast cancer.

Expected Enrollment

350 ER-positive patients will be randomized over about 1 year, and 50 
ER-negative patients will be entered on Arm II.

Outline

Partially randomized study.  Patients with ER-positive tumors are randomized 
on Arms I and II.  Patients with ER-negative tumors are entered on Arm II.
Arm I:  Antiestrogen Therapy.  Tamoxifen, TMX, NSC-180973.
Arm II:  Hormonal Therapy.  Megestrol acetate, MEG, NSC-71423.

Trial Contact Information

Trial Lead Organizations

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Patrick Byrne, MD, Protocol chair(Contact information may not be current)		Ph: 703-560-3205