Spots Global Cancer Trial Database for Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

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Trial Identification

Brief Title: Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

Official Title: Prevention of Chemotherapy-induced Menopause by Temporary Ovarian Suppression With Triptorelin Vs. Control in Young Breast Cancer Patients. A Randomized Phase III Multicenter Study [PROMISE]

Study ID: NCT00311636

Conditions

Breast Cancer

Interventions

cyclophosphamide

docetaxel

doxorubicin hydrochloride

epirubicin hydrochloride

Study Description

Brief Summary: RATIONALE: Chemotherapy may cause early menopause in premenopausal women. Triptorelin may prevent this from happening. PURPOSE: This randomized phase III trial is studying triptorelin to see how well it works in preventing early menopause in premenopausal women who are receiving chemotherapy for stage I, stage II, or stage III breast cancer that has been removed by surgery.

Detailed Description: OBJECTIVES: Primary * Evaluate the incidence of chemotherapy-induced early menopause in premenopausal women undergoing adjuvant chemotherapy in combination with vs without triptorelin for previously resected stage I-III breast cancer. Secondary * Compare the toxicity of adjuvant chemotherapy and triptorelin vs adjuvant chemotherapy alone. OUTLINE: This is a prospective, open-label, multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I (adjuvant chemotherapy alone): Patients receive adjuvant chemotherapy alone. * Arm II (adjuvant chemotherapy and triptorelin): Patients receive adjuvant chemotherapy and triptorelin intramuscularly 1 week before and then every 4 weeks for the duration of chemotherapy. The last dose of triptorelin is given before the last course of chemotherapy. Patients with hormone-sensitive tumors who resume ovarian function after stopping chemotherapy and triptorelin restart triptorelin until ovarian function is suppressed for 2 years. Patients undergo menopausal status assessment, using follicle-stimulating hormone, luteinizing hormone, and estradiol as biochemical markers, at baseline and 3, 6, 9, and 12 months after the last course of chemotherapy. After completion of study treatment, patients are followed at 3, 6, 9, and 12 months. PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study.