Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
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 May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.


Options:
A: Inclusion Criteria:

* Healthy women
* No previous history of cardiovascular disease or cancer
* No contraindications to aspirin or vitamin E
B: * 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.
C: Inclusion Criteria:

* Postmenopausal women with established coronary heart disease or at risk for a major coronary event.

Exclusion Criteria:

* Postmenopausal symptoms that required estrogen replacement therapy.
* Suspected or known history of breast or endometrial carcinoma.
* Known or probable history of deep venous thrombosis, pulmonary embolism, or retinal vein thrombosis.
* New York Heart Association classes III or IV heart failure.
D: Inclusion Criteria:

* Healthy postmenopausal women at "high risk" for breast cancer will be eligible for the study; definition of menopause will be:

  * Amenorrhea for at least 12 months, or
  * History of hysterectomy and bilateral salpingo-oophorectomy, or
  * At least 55 years of age with prior hysterectomy with or without oophorectomy, or
  * Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
  * "High risk" for breast cancer will be defined as:

    * Prior histologically confirmed lobular carcinoma in situ (LCIS) treated by local excision only, or
    * At least 1.66% probability of invasive breast cancer within 5 years using the Breast Cancer Risk Assessment Tool
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 80% or above
* Leukocytes \>= 3,000/uL
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 100,000/uL
* Total bilirubin =\< 2.0 mg/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.0 X institutional ULN
* Creatinine =\< 1 X institutional ULN
* Recent mammogram negative for breast cancer, Breast Imaging-Reporting and Data System (BIRADS) score \< 3 (within the last 12 months)
* Ability to understand and the willingness to sign a written informed consent document; only potential participants with the ability to understand and the willingness to sign a written document will be presented with an informed consenting document

Exclusion Criteria:

* Women diagnosed with osteoporosis (previously or on screening dual-energy X-ray absorptiometry \[DEXA\] for this study) and not on a stable dose of long or short-acting bisphosphonates therapy for at least 3 months will be excluded from the study; women diagnosed with osteoporosis and on raloxifene (Evista) therapy will be excluded from the study; use of calcium and/or vitamin D for osteoporosis prevention or treatment is allowed; women with osteopenia will be allowed to participate in this study
* Have had invasive cancer within the past five years except non-melanoma skin cancer
* Evidence of suspicious of malignant disease on bilateral mammogram within the past year unless ruled out by further evaluation
* History of prior invasive breast cancer or intraductal carcinoma in situ, or history of prior radiation therapy to the chest or breast
* Participants may not be receiving any other investigational agents; participants may not be concurrently enrolled in another breast cancer prevention intervention trial
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Within 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
* Within 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators
* Within 3 months since regular use (more than 2 times a week) of prior estrogenic supplements or herbal remedies
* History of bleeding or clotting disorder; current or recent (within 3 months) use of Coumadin, Plavix or other systemic anticoagulant other than aspirin is not permitted if subject chooses to participate in the optional RPFNA procedure; if a subject chooses not to participate in the RPFNA procedure, prior or current treatment with systemic anticoagulants is permitted

Answer: B