Status:
COMPLETED
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
- 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
- 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.
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04075604
Start Date
October 18 2019
End Date
July 27 2021
Last Update
August 10 2022
Active Locations (36)
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1
Local Institution - 0031
Whittier, California, United States, 90603
2
University Cancer Blood Ctr
Athens, Georgia, United States, 30607
3
Northside Hospital,Inc.- Central Research Department
Atlanta, Georgia, United States, 30342
4
Northwestern University
Chicago, Illinois, United States, 60611