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Phase III Randomized, Crossover Comparison of Megestrol Acetate vs Tamoxifen in Postmenopausal ER-Positive Women with Advanced Breast Cancer, with Megestrol Acetate in ER-Negative Patients
Basic Trial Information
Objectives I. Determine the response rate and response duration produced by single-agent therapy with tamoxifen vs. megestrol acetate in postmenopausal women with advanced breast cancer and positive estrogen receptor (ER) status. II. Determine the crossover response of postmenopausal women with advanced breast cancer and positive ER status who progress on one therapy and subsequently receive the alternate therapy. III. Determine the efficacy of single-agent therapy with megestrol acetate in postmenopausal women with advanced breast cancer having negative ER status and either positive or negative progesterone receptor (PgR) status. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Women with measurable advanced, recurrent, or metastatic breast cancer. Patients must be postmenopausal with either a physiologic menopause at least one year prior to entry or surgical castration 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. Prior therapy with progestational or antiestrogenic agents for breast cancer (either as adjuvant or active therapy) excludes. There may be no hormonal therapy during the 6 weeks prior to entry; patients who have failed on prior hormonal therapy (excluding adjuvant chemotherapy including prednisone) are ineligible. A Karnofsky performance status greater than 50% is required, and there may be no history of thrombophlebitis, thromboembolic disease, or stroke. CNS metastases requiring immediate therapy or that are the only evidence of metastatic disease exclude. Patients with another malignancy (excluding nonmelanomatous skin cancer or carcinoma in situ of the cervix) are ineligible. Expected Enrollment 175 patients will be randomized to each arm. The study is expected to require 3 years. Protocol closed August 1985. Outline Partially randomized study. Patients with positive ER status are randomized to Arms I and II; those with negative ER 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. Trial Lead Organizations Yale Cancer 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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