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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04075604
Registration number
NCT04075604
Ethics application status
Date submitted
29/08/2019
Date registered
3/09/2019
Date last updated
10/08/2022
Titles & IDs
Public title
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
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Scientific 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
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Secondary ID [1]
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CA209-7A8
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Universal Trial Number (UTN)
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Trial acronym
CheckMate 7A8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Nivolumab
Treatment: Drugs - Anastrozole
Treatment: Drugs - Palbociclib
Experimental: Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) -
Experimental: Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ -
Active Comparator: Arm C: Palbociclib+ANZ -
Other interventions: Nivolumab
Specified Dose on Specified Days
Treatment: Drugs: Anastrozole
Specified Dose on Specified Days
Treatment: Drugs: Palbociclib
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to 4 weeks after first dose
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Primary outcome [2]
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Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose up to approximately 6 months after first dose
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Secondary outcome [2]
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Breast Conserving Surgery (BCS) Rate
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Assessment method [2]
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The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method.
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Timepoint [2]
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From first dose up to approximately 6 months after first dose
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Secondary outcome [3]
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Pathological Complete Response (pCR) Rate
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Assessment method [3]
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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.
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Timepoint [3]
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From first dose up to approximately 6 months after first dose
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Secondary outcome [4]
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The Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [4]
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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.
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Timepoint [4]
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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Secondary outcome [5]
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The Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [5]
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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.
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Timepoint [5]
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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Secondary outcome [6]
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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Assessment method [6]
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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.
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Timepoint [6]
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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Secondary outcome [7]
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The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
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Assessment method [7]
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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.
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Timepoint [7]
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From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
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Secondary outcome [8]
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The Number of Participants Deaths
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Assessment method [8]
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The number of participants that have died during the study.
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Timepoint [8]
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From first dose up to approximately 8 months
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Secondary outcome [9]
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The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
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Assessment method [9]
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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
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Timepoint [9]
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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Secondary outcome [10]
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The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
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Assessment method [10]
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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
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Timepoint [10]
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From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
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Eligibility
Key inclusion criteria
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/07/2021
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Sample size
Target
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Accrual to date
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Final
23
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Recruitment in Australia
Recruitment state(s)
SA,WA
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Recruitment hospital [1]
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Local Institution - 0005 - Elizabeth Vale
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Recruitment hospital [2]
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Breast Cancer Research Centre - WA - Nedlands
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Recruitment postcode(s) [1]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Georgia
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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New Jersey
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Virginia
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Country [7]
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Belgium
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State/province [7]
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Antwerpen
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Country [8]
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Belgium
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State/province [8]
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Liege
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Country [9]
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Belgium
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State/province [9]
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Namur
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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France
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State/province [11]
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Bordeaux
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Country [12]
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France
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State/province [12]
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Creteil Cedex
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Country [13]
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France
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State/province [13]
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La Roche-sur-yon Cedex 9
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Country [14]
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France
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State/province [14]
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Lyon Cedex 08
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Country [15]
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France
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State/province [15]
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Marseille Cedex 9
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Country [16]
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France
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State/province [16]
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Montpellier
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Country [17]
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France
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State/province [17]
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TOULOUSE Cedex 9
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Country [18]
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Germany
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State/province [18]
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Bonn
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Country [19]
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Germany
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State/province [19]
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Erlangen
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Country [20]
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Germany
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State/province [20]
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Essen
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Country [21]
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Germany
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State/province [21]
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Moenchengladbach
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Country [22]
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Germany
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State/province [22]
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Saarbruecken
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Country [23]
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Puerto Rico
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State/province [23]
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Monterrey Ponce
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Country [24]
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Puerto Rico
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State/province [24]
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San Juan
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Country [25]
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Spain
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State/province [25]
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Barcelona
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Country [26]
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Spain
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State/province [26]
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Madrid
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Country [27]
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Spain
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State/province [27]
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Malaga
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Country [28]
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Spain
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State/province [28]
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Sevilla
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Country [29]
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Spain
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State/province [29]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04075604
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04075604
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