Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Inicie sesión o únase ahora para utilizar esta función

Not Yet Recruiting

A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer - CA209-7A8

Actualizada: 09 September, 2019   |   ClinicalTrials.gov

Imprimir Resumen

¿ESTÁ CONSIDERANDO PARTICIPAR EN ESTE ESTUDIO?
Imprima esta página y la guía del estudio para poder hablar mejor con su médico.
Use la guía de estudios para explorar el proceso de participación en un estudio clínico. Comprenda qué factores clave debe considerar antes de decidirse y piense preguntas para hacerle a su equipo de atención médica.

Detalles del estudio

  • Fase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 49

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm A: Nivolumab +Abemaciclib+Anastrozole (ANZ)
Drug: Anastrozole Drug: Abemaciclib Biological: Nivolumab
Experimental: Arm B: Abemaciclib+ANZ then Nivolumab+Abemaciclib+ANZ
Biological: Nivolumab Drug: Anastrozole Drug: Abemaciclib
Active Comparator: Arm C: Abemaciclib+ANZ
Drug: Anastrozole Drug: Abemaciclib
Experimental: Arm D: Nivolumab+Palbociclib+ANZ
Biological: Nivolumab Drug: Palbociclib Drug: Anastrozole
Experimental: Arm E: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ
Biological: Nivolumab Drug: Palbociclib Drug: Anastrozole
Active Comparator: Arm F: Palbociclib+ANZ
Drug: Palbociclib Drug: Anastrozole

Criterios clave de elegibilidad

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Participants must have untreated, unilateral, histologically confirmed ER+, HER2- invasive breast cancer with primary tumor ≥2 cm in largest diameter (cT1-3) in one dimension by clinical or radiographic exam, for whom neoadjuvant endocrine monotherapy deemed to be a suitable therapy. - Participants must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy and agree to provide tumor tissue at baseline, on-treatment, and at surgery. - Women must have documented proof that they are not of childbearing potential. - ECOG <=1. Exclusion Criteria: - Participants who may have had any treatment, including radiotherapy, chemotherapy, and/or targeted therapy administered for the currently diagnosed breast cancer prior to enrollment or upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment. - Participants who have a history of or active, known or suspected autoimmune disease, or other syndrome that requires systemic steroids above physiological replacement dose or autoimmune agents for the past 2 years. - Prior treatment with either ET or CDK4/6 inhibitors for Breast Cancer or an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components - Prior Malignancy active within the previous 3 years as well as or participants with serious or uncontrolled medical disorders. - Personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), long or short QT syndrome, Brugada syndrome, or known history of corrected QT prolongation, Torsade de Pointes, or sudden cardiac arrest. Other inclusion/exclusion criteria apply.

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)

Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí

Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 - Llame 855-907-3286 o Envíenos un correo electrónico

¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico