A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

Bristol-Myers Squibb23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Cancer

Interventions

NivolumabBIOLOGICAL

Specified Dose on Specified Days

AnastrozoleDRUG

Specified Dose on Specified Days

PalbociclibDRUG

Specified Dose on Specified Days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase

The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase. DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment. Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palbociclib of the cycle for reasons other than a DLT will not be considered as DLT-evaluable participants.

Time frame: From first dose to 4 weeks after first dose

Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase

RCB 0-I rate is defined as the percentage of randomized participants who achieve RCB 0: no residual disease or RCB-I: minimal residual disease. RCB is a continuous index combining pathological measurements of primary tumor (size and cellularity) and nodal metastases (number and size) defined by a point system at surgery. No participants continued to the randomized phase; trial was closed after completion of the Safety Run-in.

Time frame: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)

Secondary Outcomes

Objective Response Rate (ORR)

ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per investigator radiographic assessment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From first dose up to approximately 6 months after first dose

Breast Conserving Surgery (BCS) Rate

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Local Institution - 0031

Whittier, California, United States

University Cancer Blood Ctr

Athens, Georgia, United States

Northside Hospital,Inc.- Central Research Department

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Local Institution - 0041

Florham Park, New Jersey, United States

The Cancer Center At Hackensack University Medical Center

Hackensack, New Jersey, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Hematology-Oncology Associates Of Fredricksburg, Inc

Fredericksburg, Virginia, United States

Peninsula Cancer Institute

Newport News, Virginia, United States

Local Institution - 0005

Elizabeth Vale, South Australia, Australia

...and 26 more locations