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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) National Cancer Institute of Canada |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00090974 |
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 | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Procedure: quality-of-life assessment |
Study Type: | Observational |
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 |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Performance status
Sex
Menopausal status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Lynne Wagner, MD | Robert H. Lurie Cancer Center |
Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
Study ID Numbers: | CDR0000380937, ECOG-E1Z03, CAN-NCIC-E1Z03 |
Study First Received: | September 7, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00090974 |
Health Authority: | United States: Federal Government |
quality of life stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Anastrozole Celecoxib Skin Diseases Quality of Life |
Breast Neoplasms Exemestane Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |