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
Data Collection
Breast Diseases+2
+ Breast Neoplasms
+ Neoplasms
Summary
Study start date: January 26, 2005
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Until 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 224 locations
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, United StatesSee the locationBanner Good Samaritan Medical Center
Phoenix, United StatesCCOP - Western Regional, Arizona
Phoenix, United StatesBanner Thunderbird Medical Center
Phoenix, United States