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Phase III Comparison of High- vs Low-Dose MEG in Patients with Advanced Carcinoma of the Breast
Basic Trial Information
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 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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