Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer
Brief Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.


Options:
A: DISEASE CHARACTERISTICS:

* Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:

  * At least 12 months since spontaneous menstrual bleeding
  * Prior documented hysterectomy and bilateral salpingo-oophorectomy
  * At least 55 years of age with prior hysterectomy with or without oophorectomy
  * 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
* Histologically confirmed lobular carcinoma in situ treated by local excision only OR a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, using Breast Cancer Risk Assessment Profile
* No clinical evidence of malignancy on physical exam within the past 180 days
* No evidence of suspicious or malignant disease on bilateral mammogram within the past year
* No bilateral or unilateral prophylactic mastectomy
* No prior invasive breast cancer or intraductal carcinoma in situ
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 35 and over

Sex:

* Female

Menopausal status:

* See Disease Characteristics

Performance status:

* No restricted normal activity for a significant portion of each day

Life expectancy:

* At least 10 years

Hematopoietic:

* Granulocyte count at least 1,500/mm\^3
* Complete blood count and differential normal
* Platelet count normal

Hepatic:

* SGOT or SGPT normal
* Bilirubin normal
* Alkaline phosphatase normal

Renal:

* Creatinine normal

Cardiovascular:

* No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
* No deep vein thrombosis

Pulmonary:

* No pulmonary embolus

Other:

* No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No concurrent nonmalignant disease that would preclude administration of tamoxifen or raloxifene
* No clinical depression, psychiatric condition, or addictive disorder
* No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* At least 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
* At least 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators of less than 3 months duration
* Concurrent Estring allowed

Radiotherapy:

* No prior breast radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No prior systemic adjuvant therapy for breast cancer
* No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)

  * NSABP-P-1 patients who received placebo are eligible
* No concurrent warfarin or cholestyramine
* Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed
B: 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
C: Inclusion Criteria:

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

* Voluntary written informed consent, and who were willing and able to make reasonable efforts to observe all clinical trial requirements were to be enrolled
* Subjects were to be postmenopausal (naturally or surgically) women, from 60 to 85 years of age (inclusive) at entry
* Screening BMD of the total hip and/or spine had to be equal to or lower than 2.5 SD T-score for subjects without an asymptomatic fracture or equal to or lower than -2.0 SD T-score for subjects with an asymptomatic fracture
* Subjects were to have a Body Mass Index (BMI) = 34 kg/m\^2.

Exclusion Criteria:

Subjects with any of the following conditions were not to be enrolled into the trial:

* Recent acute vertebral fracture (diagnosed within the last year) documented by spinal radiograph requiring medication for osteoporosis treatment, in the judgment of the investigator
* More than two prevalent asymptomatic vertebral fractures at baseline
* Screening BMD of the total hip or spine lower than -4 SD T-score
* Unsuitable anatomy on spinal radiographs (lumbar and thoracic vertebrae) e.g., excessive scoliosis
* Not ambulatory
* History or presence of any malignancy within the past five years except for nonmelanoma skin cancer. Subjects with ever history of ovarian cancer or estrogen dependent tumors particularly breast or endometrial cancer were to be excluded
* Trans vaginal ultrasound (TVUS) endometrial double wall thickness \>4 mm
* Unexplained abnormal vaginal bleeding in the past year prior to screening
* Abnormal cervical Papanicolaou (Pap) smear (including low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL), atypical squamous cells of undetermined significance (ASCUS), atypical glands of undetermined significance (AGCUS))
* Mammography finding that was suspicious of malignancy
* Bone disease other than osteoporosis such as Paget's disease, osteomalacia, hyperparathyroidism, or bone metastases
* Treatment with anabolic steroids, calcitonin, raloxifene, tamoxifen, or calcitriol within the last six months prior to screening BMD or spinal X-ray measurements.
* Treatment with systemic estrogen and/or progestin within the last three months prior to screening BMD or spinal X-ray measurements (occasional use of estriol containing vaginal cream was allowed)
* Treatment with bisphosphonates for one month or more within the last year
* Ever use of estrogen and/or progestin containing implants

Answer: A