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Phase III Randomized Comparison of Megestrol Acetate vs Tamoxifen for Advanced Breast Cancer in Postmenopausal Patients
Basic Trial Information
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 Lead Organizations Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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