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Phase III Randomized, Crossover Comparison of Megestrol Acetate vs Tamoxifen in Patients with Metastatic Breast Cancer
Basic Trial Information
Objectives I. Determine the response rate and duration of remission of single-agent therapy with megestrol acetate vs. tamoxifen in postmenopausal women with advanced breast cancer who have positive estrogen receptor (ER) and either positive or negative progesterone receptor (PgR) status. II. Determine the crossover response of postmenopausal women with advanced breast cancer (and positive ER and either positive or negative PgR status) who progress on either megestrol acetate or tamoxifen and subsequently receive the alternate therapy. III. Monitor the side effects and patterns of toxicity of single-agent therapy with megestrol acetate vs. tamoxifen. IV. Determine the efficacy of single-agent therapy with megestrol acetate in postmenopausal women with advanced breast cancer who have negative ER and either positive or negative PgR status. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically proven Stage IV breast cancer. Patients must be postmenopausal with either a physiologic menopause at least 1 year prior to entry or surgical castration (bilateral oophorectomy) 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; androgen and glucocorticoid receptor status will also be determined for any patient who has a tumor biopsy at the time of entry. Disease must be measurable; for bone sites to be considered measurable, disease must be osteolytic or mixed sclerotic/lytic. Patients with quiescent disease (i.e., no evidence of progression within 6 months prior to entry) are ineligible. The Karnofsky performance status must be at least 50%, and patients must have recovered from all toxicity and side effects of prior therapy. At least 6 weeks must have elapsed since prior hormonal therapy. Patients who have received prior treatment with progestational or antiestrogenic agents for breast cancer, either as adjuvant therapy or as therapy for metastatic disease, are ineligible; prior adjuvant chemotherapy including prednisone or other glucocorticoids is allowed. Patients who failed to respond to prior hormonal or ablative therapy for breast cancer are ineligible. There may be no brain metastases or CNS lesions that require immediate therapy or that are the only evident metastases. Thrombophlebitis, thromboembolic disorder, stroke, or a history of these conditions excludes. There may be no evidence of other primary cancer, except for superficial nonmelanomatous skin cancer or carcinoma in situ of the cervix. Patients with other existing conditions for which hormonal therapy is contraindicated or deemed inappropriate by the investigator (e.g., liver involvement of greater than 25%, lymphangitic pulmonary disease, or inflammatory breast carcinoma) or for which other therapy (radiotherapy or chemotherapy) is deemed more appropriate, are ineligible. Pregnancy excludes. Expected Enrollment A minimum of 400 evaluable patients will be entered. 175 ER-positive patients will be randomized to each arm for a total of 350 patients; 50 ER-negative patients will be accrued. Protocol closed October 1984. Outline Partially randomized study. Patients with positive ER status and either positive or negative PgR status are randomized to Arms I and II; those with negative ER status and either positive or negative PgR 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.Related Publications Kuss J, Muss H, Hoen H, et al.: Tamoxifen (Tam) as initial endocrine therapy for advanced breast cancer (ABC): long term follow-up. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-87, 71, 1993. Trial Lead Organizations Piedmont Oncology Association Regional Cooperative Group
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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