Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

OBJECTIVES:

Primary

- Compare treatment-related symptoms using the Functional Assessment of Cancer
Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with
receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with
exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.

Secondary

- Compare health-related quality of life using the FACT-ES questionnaire in patients
treated with these regimens.

- Determine the extent to which differences in treatment-emergent symptoms affect overall
quality of life in patients treated with these regimens.

OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.

Health-related quality of life and treatment-related symptoms are assessed using the
Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at
baseline and at 3, 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.

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