Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: exemestane
Intervention description: one 25 mg tablet daily in am
Intervention MeSH terms: Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4560.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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.
    

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.