a study on Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.
Breast Cancer stage II breast cancer stage IIIA breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer stage IA breast cancer stage IB breast cancer Triptorelin Pamoate Tamoxifen Exemestane
For females ages 18–65
Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months
No systemic hepatic disease that would preclude prolonged follow-up
No systemic renal disease that would preclude prolonged follow-up
No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable
No systemic pulmonary disease that would preclude prolonged follow-up
PRIOR CONCURRENT THERAPY:
Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed
No prior neoadjuvant or adjuvant chemotherapy
No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)
No prior ovarian radiotherapy
No prior bilateral oophorectomy
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