exemestane in preventing cancer in postmenopausal women at increased risk of developing breast cancer

Conditions: Breast Cancer

Summary: rationale: the map.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. purpose: the study protocol was amended in may 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

objectives: primary previously: to determine if exemestane reduces the incidence of invasive breast cancer compared with placebo. currently: to determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy. secondary previously: (same as is currently listed in pdq) currently: to address the trial committee and sponsor's commitment to allow women who are randomized to the map.3 trial to receive 5 years of exemestane therapy. outline: this study was a randomized, double-blind, placebo-controlled, multicentre study. protocol-specified analyses were performed in april 2011. the results of these analyses are posted in the results section. following the amendment of may 2011, the study is now open-label and all eligible patients are receiving exemestane from participating sites for a total of 5 years. after exemestane is stopped, there is no further follow-up. projected accrual:there were 4560 women from the united states, canada, spain and france who took part in this study.

Eligibility criteria:
* at increased risk of developing breast cancer, due to at least one of the following risk factors: * gail score ≥ 1.66 * age ≥ 60 years * prior atypical ductal hyperplasia, lobular hyperplasia, or lobular carcinoma in situ on breast biopsy * prior ductal carcinoma in situ (dcis) treated with total mastectomy with or without tamoxifen (tamoxifen must have been completed ≥ 3 months prior to randomization) * no prior dcis treated with lumpectomy with or without radiation * no prior invasive breast cancer * not brca1 or brca2 carriers patient characteristics: previous: * 35 and over * female * postmenopausal, defined as one of the following: * over 50 years of age with no spontaneous menses for at least 12 months before study entry * 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry and with follicle-stimulating hormone level within postmenopausal range * underwent prior bilateral oophorectomy * no other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years * no uncontrolled hypothyroidism or hyperthyroidism * no major medical or psychiatric illness (including substance and alcohol abuse within the past 2 years) that would preclude study participation or compliance * must be accessible for treatment and follow-up * willing to complete quality of life questionnaires in either english or french current: map.3 participants who were randomized to the exemestane arm, are currently receiving exemestane as part of the map.3 study and who have not completed 5 years of exemestane. or map.3 study participants who were randomized to the placebo arm and who have either completed 5 years of study drug or who are still receiving placebo. note: this applies only to centres that choose to allow placebo "cross-over". prior concurrent therapy: previous: * more than 3 months since prior and no concurrent hormone replacement therapies * more than 3 months since systemic estrogenic, androgenic, or progestational agents * more than 3 months since prior and no concurrent hormonal therapies, including, but not limited to the following: * luteinizing-hormone releasing-hormone analogs (e.g., goserelin or leuprolide) * progestogens (e.g., megestrol) * prolactin inhibitors (e.g., bromocriptine) * antiandrogens (e.g., cyproterone acetate) * selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene) * no investigational drug within 30 days or 5 half lives prior to randomization * no concurrent endocrine therapy * no concurrent estrogens, androgens, or progesterones * concurrent low dose (≤ 100 mg/day) prophylactic aspirin allowed * concurrent bisphosphonates for prevention or treatment of osteoporosis allowed * no other concurrent medications that may have an effect on study endpoints current: there are no prior concurrent therapy restrictions for the amended map.3 study.

Keywords: breast cancer