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.

Condition	Treatment or Intervention
Quality of Life stage I breast cancer stage II breast cancer stage IIIA breast cancer	Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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 .

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 .

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.

Genders Eligible for Study:  Both

Criteria

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 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

Illinois
      Evanston Northwestern Healthcare - Chicago, Chicago,  Illinois,  60611,  United States; Recruiting

Study chairs or principal investigators

Lynne Wagner, MD,  Study Chair,  Evanston Northwestern Healthcare - Chicago   
Paul Edward Goss, MD, PhD,  Study Chair,  Massachusetts General Hospital   

Study ID Numbers:  CDR0000380937; ECOG-E1Z03; CAN-NCIC-E1Z03; NCT00090974
Record last reviewed:  December 2004
Last Updated:  March 10, 2005
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090974
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08