Status:
COMPLETED
Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Lead Sponsor:
NCIC Clinical Trials Group
Collaborating Sponsors:
Grupo Espanol de Investigacion del Cancer de Mama
UNICANCER
Conditions:
Breast Cancer
Eligibility:
FEMALE
35+ years
Phase:
PHASE3
Brief 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 M...
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 3 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2018
Estimated Enrollment :
4560 Patients enrolled
Trial Details
Trial ID
NCT00083174
Start Date
December 3 2004
End Date
January 22 2018
Last Update
August 25 2023
Active Locations (76)
Enter a location and click search to find clinical trials sorted by distance.
1
Jefferson Clinic, P.C.
Birmingham, Alabama, United States, 35233
2
UAB Comprehensive Cancer Center-LNB 301
Birmingham, Alabama, United States, 35294-0111
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
University of California, San Diego
La Jolla, California, United States, 92037