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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

Breast Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00090974
Study type Observational
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase
Start date January 26, 2005
Completion date January 30, 2013
View Details
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