Please select the eligibility criteria that correspond to the clinical trial below.
Title: Raloxifene Hydrochloride or Placebo in Postmenopausal Women at Risk for Major Coronary Events
Brief Summary: The purpose of this study is to determine whether raloxifene compared with placebo lowers the risk of coronary events and reduces the risk of invasive breast cancer in postmenopausal women at risk for major coronary events.


Options:
A: Inclusion Criteria:

* Female, 65-89 years old
* No history of severe liver, kidney or eye disease

Exclusion Criteria:

* Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate)
* Using hip protectors

Other protocol-defined inclusion/exclusion criteria may apply.
B: Postmenopausal women ages 50 to 79.
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: 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

Answer: C