Suspendido

Predictores genéticos para síntomas musculoesqueléticos de inhibidores de aromatasa en pacientes con cáncer de mama

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Objetivo del estudio

Este estudio tiene como objetivo identificar predictores genéticos, específicamente Polimorfismos de Nucleótido Único (SNPs), asociados con la interrupción del tratamiento con Inhibidores de la Aromatasa (AI) debido a síntomas musculoesqueléticos en pacientes con cáncer de mama, dentro de un periodo de 12 meses.

Qué se está evaluando

Tratamiento oral con Anastrozole

Medicamento
Quiénes están siendo reclutados

Enfermedades de la Mama+2

+ Neoplasias

+ Neoplasias por Sitio

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Cuidados de Apoyo

Intervencional
Inicio del estudio: junio de 2013
Ver detalles del protocolo

Resumen

Patrocinador PrincipalECOG-ACRIN Cancer Research Group
Última actualización: 27 de agosto de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 11 de junio de 2013

Fecha en la que se inscribió al primer participante.

PRIMARY OBJECTIVES: I. To validate previously identified associations between 10 specific single nucleotide polymorphisms (single nucleotide polymorphisms \[SNPs\]) and discontinuation of treatment with aromatase inhibitors (AIs) due to the development of musculoskeletal symptoms (MSS) among women with breast cancer. SECONDARY OBJECTIVES: I. To determine whether other SNPs in cytochrome P450 enzymes (CYP), glucuronosyltransferases (UGT), Vitamin D, serotonin and other receptors are associated with discontinuation of treatment due to the development of severe aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). II. To determine whether other SNPs in CYP, UGT, Vitamin D, serotonin and other receptors are associated with the development of other potential complications of AI therapy. III. To develop a gene signature that can identify patients at risk for developing severe anastrozole-related AIMSS and other potential complications of AI therapy. IV. To determine the epidemiology and predictors of severe AIMSS and of AI discontinuation. V. To describe patient reported outcomes for minority patients with breast cancer treated with AIs. VI. To assess the utility of the Patient Reported Outcomes Management Information System (PROMIS) system to collect patient reported outcomes in a cooperative group study, and validate the PROMIS Physical Function 20a form in patients with AIMSS. VII. To develop a model that incorporates patient ratings of treatment burden, fear of recurrence and adherence behaviors to describe patient decisions to continue or discontinue anastrozole. VIII. To collect serum samples for future testing for biomarkers of AIMSS. OUTLINE: Patients receive anastrozole orally (PO) once daily (QD) for 12 months. After the completion of study treatment, patients are followed up for 12 months.

NCT01824836
Patrocinador PrincipalECOG-ACRIN Cancer Research Group
Última actualización: 27 de agosto de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 1046 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Cuidados de Apoyo

Estos estudios exploran maneras de mejorar el confort y la calidad de vida diaria de las personas que viven con una condición. Pueden centrarse en aliviar síntomas, reducir efectos secundarios del tratamiento o apoyar el bienestar general.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Enfermedades de la MamaNeoplasiasNeoplasias por SitioEnfermedades de la PielNeoplasias de la Mama

Criterios

Inclusion Criteria: * Patients must be post-menopausal; post-menopausal will be defined as women meeting any of the following criteria: * \>= 60 years of age; or * \< 60 years of age and amenorrheic for \>= 12 months prior to day 1 if uterus/ovaries are intact; or * \< 60 years of age, and the last menstrual period 6-12 months prior to day 1, if intact uterus/ovaries and meets biochemical criteria for menopause (follicle-stimulating hormone \[FSH\] and estradiol within institutional standard for postmenopausal status); or * \< 60 years of age, without a uterus, and meets biochemical criteria for menopause (FSH and estradiol within institutional standards for postmenopausal status); or * \< 60 years of age and history of bilateral oophorectomy; surgery must have been completed at least 4 weeks prior to day 1; or * Prior radiation castration with amenorrhea for at least 6 months * Patients must have estrogen and/or progesterone receptor positive histologically confirmed stage I-III adenocarcinoma of the breast * Patients must have completed recommended local therapy and adjuvant chemotherapy for breast cancer * Plan to treat with anastrozole for at least 12 months * Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 * Patients must be disease-free of other prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. Prior early stage breast cancers are also allowed as long as prior treatment did not include aromatase inhibitors. * Patients must have worst pain rated as less than 4 out of 10 on the following question: "In the past week, how much pain have you had on a scale of 0 to 10, where 0 equals no pain and 10 means the worst pain you can imagine; " NOTE: This question regarding patient's pain should be completed within one week prior to registration; this pain item may be completed orally prior to consent up to 7 days prior to registration; it is not necessary to complete this pain item via the PROMIS website * Patients must have adequate hepatic, hematologic and renal functioning to be able to be administered anastrozole at the discretion of the treating physician Exclusion Criteria: * Prior AI therapy with exemestane, letrozole, or anastrozole as adjuvant therapy or for prevention of breast cancer; prior tamoxifen as adjuvant therapy or for prevention is allowed * Patients must not be currently taking (or have taken in the past 6 months) ongoing, daily analgesic medication for active, chronic conditions (i.e., rheumatoid arthritis, carpal tunnel syndrome, tenosynovitis, systemic lupus erythematosus, gout, fibromyalgia, or severe osteoarthritis involving the hands, wrists, hips, knees, feet or ankles); (note: patients taking daily low dose aspirin are allowed to participate in this trial) * Prior history of deep vein thrombosis (DVT) or pulmonary embolism in the past 5 years

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Los participantes en este grupo reciben una dosis oral diaria de anastrozole durante 12 meses. Esto forma parte del tratamiento experimental que se está probando.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene 2 ubicaciones

Eastern Cooperative Oncology Group

Boston, United StatesAbrir Eastern Cooperative Oncology Group en Google Maps

Veterans Adminstration New Jersey Health Care System

East Orange, United States
Suspendido2 Centros de Estudio