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

July 14, 2022 updated by: Bristol-Myers Squibb

Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Local Institution - 0005
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Breast Cancer Research Centre - WA
  • Belgium
      • Liege, Belgium, 4000
        • Local Institution
      • Namur, Belgium, 5000
        • Local Institution
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • Local Institution - 0011
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Local Institution - 0071
  • France
      • Bordeaux, France, 33077
        • Local Institution - 0075
      • Creteil Cedex, France, 94010
        • Local Institution - 0073
      • La Roche-sur-yon Cedex 9, France, 85925
        • Local Institution - 0072
      • Lyon Cedex 08, France, 69373
        • Centre Léon Bérard
      • Marseille Cedex 9, France, 13273
        • Local Institution - 0019
      • Montpellier, France, 34070
        • Centre de Cancerologie du Grand Montpellier
      • TOULOUSE Cedex 9, France, 31059
        • Institut Claudius Regaud
  • Germany
      • Bonn, Germany, 53111
        • Local Institution
      • Erlangen, Germany, 91054
        • Local Institution
      • Essen, Germany, 45136
        • Klinik Essen-Mitte
      • Moenchengladbach, Germany, 41061
        • Local Institution
      • Saarbruecken, Germany, 66113
        • Local Institution
  • Puerto Rico
      • Monterrey Ponce, Puerto Rico, 00731
        • Local Institution - 0047
      • San Juan, Puerto Rico, 00927
        • Local Institution - 0002
      • San Juan, Puerto Rico, 00936
        • Local Institution - 0062
  • Spain
      • Barcelona, Spain, 08035
        • H. Univ. Vall dHebron
      • Barcelona, Spain, 08036
        • Local Institution - 0037
      • Madrid, Spain, 28041
        • Hosp Univer 12 De Octubre
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
  • United States
    • California
      • Whittier, California, United States, 90603
        • Local Institution - 0031
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer Blood Ctr
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital,Inc.- Central Research Department
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Local Institution - 0041
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center at Hackensack University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Hematology-Oncology Associates Of Fredricksburg, Inc
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
Time Frame: From first dose to 4 weeks after first dose
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.
From first dose to 4 weeks after first dose
Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
Time Frame: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)

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.
From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From first dose up to approximately 6 months after first dose
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.
From first dose up to approximately 6 months after first dose
Breast Conserving Surgery (BCS) Rate
Time Frame: From first dose up to approximately 6 months after first dose
The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method.
From first dose up to approximately 6 months after first dose
Pathological Complete Response (pCR) Rate
Time Frame: From first dose up to approximately 6 months after first dose
The percentage of participants with an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Confidence interval based on the Clopper and Pearson method.
From first dose up to approximately 6 months after first dose
The Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The number of participants experiencing adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The Number of Participants Experiencing Serious Adverse Events (SAEs)
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The number of participants experiencing serious adverse events (SAEs). A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The number of participants experiencing adverse events (AEs) that lead to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
Time Frame: From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
The number of participants experiencing adverse events that are immune-related. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
The Number of Participants Deaths
Time Frame: From first dose up to approximately 8 months
The number of participants that have died during the study.
From first dose up to approximately 8 months
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units.

TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units.

ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA209-7A8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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