This trial is active, not recruiting.

Condition breast cancer
Treatment quality-of-life assessment
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date December 2004
Trial identifier NCT00090974, CAN-NCIC-E1Z03, CDR0000380937, ECOG-E1Z03


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.

United States No locations recruiting
Other countries No locations recruiting

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).