A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Condition: Breast Cancer; Cancer
MeSH terms: Breast Neoplasms
Intervention: Nivolumab; Anastrozole; Palbociclib
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Palbociclib; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nivolumab; Breast Cancer; Cancer; ER+; HER2-; Neoadjuvant

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.