A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Cancer

Treatments: Biological: Nivolumab; Drug: Palbociclib; Drug: Anastrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04075604

CA209-7A8

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 3 patient groups

Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ)

Experimental group

Treatment:

Drug: Palbociclib

Drug: Anastrozole

Biological: Nivolumab

Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ

Experimental group

Treatment:

Drug: Palbociclib

Drug: Anastrozole

Biological: Nivolumab

Arm C: Palbociclib+ANZ

Active Comparator group

Treatment:

Drug: Palbociclib

Drug: Anastrozole