Elsevier

Clinical Breast Cancer

Volume 7, Issue 11, December 2007, Pages 895-900
Clinical Breast Cancer

Current Trial
National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: Evaluation of Exemestane to Prevent Breast Cancer in Postmenopausal Women

https://doi.org/10.3816/CBC.2007.n.057Get rights and content

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      Women with an intact uterus require combination HRT because unopposed oestrogen increases uterine cancer risk, but combined HRT may further increase the risk of breast cancer [36] which is important for BRCA1 and BRCA2 mutation carriers who have a high-background breast cancer risk. Although hysterectomy eliminates the risk of uterine cancer in mutation carriers who choose tamoxifen for treatment or prevention of breast cancer, the use of an aromatase inhibitor instead of tamoxifen is an alternative approach and is not associated with uterine cancer [37–40]. Precisely estimating the true increased risk, if any, of uterine cancer in BRCA1 and BRCA2 mutation carriers will need a large multi-national study or meta-analysis; in the meantime, we do not believe that routine hysterectomy at RRSO is justified in the vast majority of BRCA1 and BRCA2 mutation carriers.

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      Secondary endpoints include total incidence of invasive and noninvasive (DCIS) breast cancer and other malignancies with EXE compared to placebo; incidence of hormone receptor–negative invasive breast cancer; incidence of noninvasive/premalignant breast lesions (LCIS, ADH, atypical lobular hyperplasia) and number of clinical breast biopsies; incidence of adverse events, with emphasis on clinical fractures (especially hip and vertebral fractures) and clinically relevant cardiac events; and comparison of quality-of-life measures, as assessed by the Short Form-36 General Health Survey and the Menopause-Specific Quality of Life Questionnaire. Biospecimens also are being collected42 and bone mineral density and annual mammograms are being obtained.42,48 The NCI Canada's Mammary 17 (MA.17) trial used an extended adjuvant design (Figure 1).49

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