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

Eastern Cooperative Oncology Group

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: quality-of-life assessment

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00090974

CAN-NCIC-E1Z03

U10CA021115 (U.S. NIH Grant/Contract)

ECOG-E1Z03

CDR0000380937

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: Under 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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