Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer (ExCel)
Breast Cancer

About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer
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.
Sites / Locations
- Jefferson Clinic, P.C.
- UAB Comprehensive Cancer Center-LNB 301
- Providence Alaska Medical Center
- University of California, San Diego
- University of California at Davis
- Los Angeles Biomedical Research Institute
- University of Connecticut Health Center
- Whittingham Cancer Center at Norwalk Hospital
- The George Washington University
- Mayo Clinic Jacksonville
- University of Miami School of Medicine
- Georgia Cancer Specialists
- John H. Stroger, Jr Hospital of Cook County
- Mercy Hospital and Medical Center
- The University of Chicago Medical Center
- Loyola University Medical Centre
- Trinity Medical Center
- Mid-Illinois Hematology and Oncology Associates, Ltd.
- Carle Cancer Centre
- Indiana University Medical Center
- University of Kansas Medical Center
- Maine Center for Cancer Medicine and Blood Disorders
- Suburban Hospital Cancer Program
- MedStar Health Research Institute
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Hutzel Women's Health Specialists
- William Beaumont Hospital
- Mayo Clinic Rochester
- Washington University School of Medicine
- University of Medicine and Dentistry of New Jersey
- Montefiore Medical Center
- Kinston Medical Specialists
- University of Cincinnati, Barrett Cancer Centre
- University of Oklahoma
- Abramson Cancer Center of the
- The Memorial Hospital of Rhode Island
- Fletcher Allen Health Care
- Fred Hutchinson Cancer Research Center
- Univ. of Wisconsin Center for Women's Health and
- Medical College of Wisconsin
- BCCA - Cancer Centre for the Southern Interior
- BCCA - Vancouver Cancer Centre
- CancerCare Manitoba
- Atlantic Health Sciences Corporation
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston
- London Regional Cancer Program
- Ottawa Health Research Institute - General Division
- Meadowlands Family Health Centre
- Algoma District Cancer Program
- Northeast Cancer Center Health Sciences
- Toronto East General Hospital
- Odette Cancer Centre
- Mount Sinai Hospital
- Univ. Health Network-Princess Margaret Hospital
- Women's College Hospital
- Hopital Maisonneuve-Rosemont
- CHUM - Hopital Notre-Dame
- CHUM - Pavillon Saint-Luc
- CHA-Hopital Du St-Sacrement
- CRLCC - Paul Papin
- CHU-Hopital A. Morvan
- Centre Francois Baclesse
- CHU de Limoges - Hopital Mere Enfant
- CHU - Hopital Arnaud de Villeneuve
- Centre Rene Gauducheau
- Clinique Hartmann
- AP-HP Hopital Tenon
- Institut Jean Godinot
- Centre Henri Becquerel
- Centre Rene Huguenin
- Centre Alexis Vautrin
- Institut Gustave-Roussy
- Orocovis Medical Center
- Altamira Family Research Center
Arms of the Study
Arm 1
Other
Exemestane
one 25 mg tablet daily in am