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

• Status: Completed
• Trial end date: 2018-01-22
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborators: Grupo Espanol de Investigacion del Cancer de Mama; UNICANCER
• Treatments: Exemestane

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.