Breast Cancer Clinical Trial
Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing 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.
Full Description
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.
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There are 76 Locations for this study
Birmingham Alabama, 35233, United States
Birmingham Alabama, 35294, United States
Anchorage Alaska, 99508, United States
La Jolla California, 92037, United States
Sacramento California, 95817, United States
Torrance California, 90502, United States
Farmington Connecticut, 06032, United States
Norwalk Connecticut, 06856, United States
Washington District of Columbia, 20037, United States
Jacksonville Florida, 32224, United States
Miami Florida, 33136, United States
Tucker Georgia, 30084, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60637, United States
Maywood Illinois, 60153, United States
Moline Illinois, 61265, United States
Normal Illinois, 61761, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66160, United States
Scarborough Maine, 04074, United States
Bethesda Maryland, 20817, United States
Hyattsville Maryland, 20782, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48201, United States
Royal Oak Michigan, 48073, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Newark New Jersey, 07107, United States
Bronx New York, 10461, United States
Kinston North Carolina, 28501, United States
Cincinnati Ohio, 45219, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19104, United States
Pawtucket Rhode Island, 02860, United States
Burlington Vermont, 05401, United States
Seattle Washington, 98109, United States
Madison Wisconsin, 53715, United States
Milwaukee Wisconsin, 53226, United States
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R3E 0, Canada
Saint John New Brunswick, E2L 4, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 8, Canada
Ottawa Ontario, K2C 3, Canada
Sault Ste. Marie Ontario, P6B 0, Canada
Sudbury Ontario, P3E 5, Canada
Toronto Ontario, M4C 3, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 1, Canada
Toronto Ontario, M5G 2, Canada
Toronto Ontario, M5S 1, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3X 3, Canada
Quebec City Quebec, G1S 4, Canada
Angers , 49933, France
Brest , 29608, France
Caen , 14076, France
Limoges , 87042, France
Montpellier , 34295, France
Nantes , 44805, France
Neuilly-sur-Seine , 92200, France
Paris , 75970, France
Reims , 51056, France
Rouen , 76038, France
Saint Cloud , 92210, France
Vandoeuvre les Nancy , 54500, France
Villejuif , 94805, France
Orocovis , 00720, Puerto Rico
San Juan , 00920, Puerto Rico
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