Breast Cancer Clinical Trial
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Summary
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
Eligibility Criteria
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.
Participants must have a performance status (PS) ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale
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 for whom 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 (BC) within 5 years 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 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 protocol-defined inclusion/exclusion criteria apply.
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There are 36 Locations for this study
Whittier California, 90603, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60611, United States
Florham Park New Jersey, 07932, United States
Hackensack New Jersey, 07601, United States
Cleveland Ohio, 44109, United States
Fredericksburg Virginia, 22408, United States
Newport News Virginia, 23601, United States
Elizabeth Vale South Australia, 5112, Australia
Nedlands Western Australia, 6009, Australia
Wilrijk Antwerpen, 2610, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Ottawa Ontario, K1H 8, Canada
Bordeaux , 33077, France
Creteil Cedex , 94010, France
La Roche-sur-yon Cedex 9 , 85925, France
Lyon Cedex 08 , 69373, France
Marseille Cedex 9 , 13273, France
Montpellier , 34070, France
TOULOUSE Cedex 9 , 31059, France
Bonn , 53111, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Moenchengladbach , 41061, Germany
Saarbruecken , 66113, Germany
Monterrey Ponce , 00731, Puerto Rico
San Juan , 00927, Puerto Rico
San Juan , 00936, Puerto Rico
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
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