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
Collecte de données
Maladies du sein+3
+ Néoplasmes du sein
+ Néoplasmes par site
Résumé
Date de début de l'étude : 26 janvier 2005
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 120 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 224 sites
Meeker County Memorial Hospital
Litchfield, United StatesOuvrir Meeker County Memorial Hospital dans Google MapsSt. John's Hospital
Maplewood, United StatesVirginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, United StatesCentraCare Clinic - River Campus
Saint Cloud, United States