Please select the eligibility criteria that correspond to the clinical trial below.
Title: Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
Brief Summary: RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.

PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.


Options:
A: Inclusion Criteria:

* The patient will satisfy the DSM-IV criteria for dementia of the Alzheimer's type.
* The patient will satisfy the NINCDS/ADRDA criteria for the clinical diagnosis of probable Alzheimer's disease (Appendix I).
* The severity of dementia for each patient will be quantified by a Mini-Mental State Examination (MMSE) score between 10 and 26 (both inclusive).
* The patient is living at home or in a home for the elderly.
* The patient has a responsible caregiver who is able to provide information about the patient's functional status.
* Written informed consent is obtained from the patient or the legally accepted representative.

Exclusion Criteria:

* The patient satisfies the NINDS-AIREN criteria for probable vascular dementia.
* A known exaggerated pharmacological sensitivity or allergy to NSAID's.
* History of peptic ulceration, gastric surgery or gastrointestinal bleeding.
* Current diagnosis of active peptic ulceration.
* Current diagnosis of severe and unstable cardiovascular disease.
* Current diagnosis of renal failure.
* Advanced, severe and unstable disease of any type, other than Alzheimer's disease, that may interfere with primary and secondary variable evaluations, including a medical condition which should be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk.
* Intake of any of the following concomitant medications: salicylates, coumarin derivatives, ACE-inhibitors, loop diuretics.
* Intake of any of the following concomitant medications more than two months immediately prior or during the study: NSAID's, systemic corticosteroids.
* Intake of any of the following concomitant medications with a possible effect on cognition: estrogen, deprenyl, vitamin E, neuroleptics, anticholinergics. Patients using stable doses of cholinesterase inhibitors were eligible, with the provision that the dose should not be changed during the study. Cholinesterase inhibitors could not be initiated during the study.
* Excessive use of alcohol (more than 5 units per day)
* The patient is, either alone or with the aid of a caregiver, not able to reliably take the medication.
B: Inclusion Criteria:

* Have had a diagnosis of probable Alzheimer's disease.
* Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
* Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
* Ability to read and understand English or Spanish to ensure compliance with cognitive testing and study visit procedures.
* Female subjects must be surgically sterile or postmenopausal for \> 1 year.
* Subjects currently taking approved medication for Alzheimer's disease for at least six months prior to day 1 may be enrolled.
* Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

* Current evidence of other causes of dementia.
* History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
* Chronic or acute renal, hepatic or metabolic disorder.
* Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
* Major surgery and related complications not resolved within 12 weeks prior to Day 1.
C: Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

* Diabetes mellitus
* Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
* Smoker at time of qualifying stroke
* Obesity (BMI\>30; BMI=weight (kg)/\[height (m)\]2)
* Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
* End-organ-damage (retinopathy, LVH, or microalbuminuria)
* Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.
D: DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer

  * pT1-3; pNX, pN0-2 or pN3\*; M0 NOTE: \*Only when the sole basis for this classification is the presence of 10 or more involved axillary lymph nodes
* Registered on protocol CAN-NCIC-MA27 within the past week
* Hormone receptor status:

  * Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥ 10 fmol/mg protein
  * At least 1 tumor must be receptor-positive in patients with bilateral breast cancer

PATIENT CHARACTERISTICS:

Age

* Postmenopausal

Performance status

* ECOG 0-2

Sex

* Female

Menopausal status

* Postmenopausal

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Able to read, understand, and complete quality of life questionnaires

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Answer: D