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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04075604
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : October 22, 2020
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Breast Cancer Cancer Biological: Nivolumab Drug: Anastrozole Drug: Palbociclib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : April 28, 2022
Estimated Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) Biological: Nivolumab
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days

Drug: Palbociclib
Specified Dose on Specified Days

Experimental: Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ Biological: Nivolumab
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days

Drug: Palbociclib
Specified Dose on Specified Days

Active Comparator: Arm C: Palbociclib+ANZ Drug: Anastrozole
Specified Dose on Specified Days

Drug: Palbociclib
Specified Dose on Specified Days

Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: up to 4 weeks ]
  2. Residual Cancer Burden RCB (0-1) rate by central assessment [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: up to 34 weeks ]
  2. Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 34 weeks ]
  3. AEs leading to Discontinuation [ Time Frame: up to 34 weeks ]
  4. Immune-related AEs [ Time Frame: up to 34 weeks ]
  5. Number of laboratory abnormalities [ Time Frame: up to 34 weeks ]
  6. Pathological Complete Response (pCR) by local assessment [ Time Frame: up to 20 weeks ]
  7. Objective Response Rate (ORR) [ Time Frame: up to 20 weeks ]
  8. Breast Conserving Surgery (BCS) rate [ Time Frame: up to 20 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04075604

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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email:
Contact: First line of the email MUST contain NCT # and Site #

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT04075604    
Other Study ID Numbers: CA209-7A8
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs