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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CA209-7A8
Universal Trial Number (UTN)
Trial acronym
CheckMate 7A8
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 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 -


Treatment: Other: Nivolumab
Specified Dose on Specified Days

Treatment: Drugs: Anastrozole
Specified Dose on Specified Days

Treatment: Drugs: Palbociclib
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From first dose to 4 weeks after first dose
Primary outcome [2] 0 0
Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From first dose up to approximately 6 months after first dose
Secondary outcome [2] 0 0
Breast Conserving Surgery (BCS) Rate
Assessment method [2] 0 0
The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method.
Timepoint [2] 0 0
From first dose up to approximately 6 months after first dose
Secondary outcome [3] 0 0
Pathological Complete Response (pCR) Rate
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
From first dose up to approximately 6 months after first dose
Secondary outcome [4] 0 0
The Number of Participants Experiencing Adverse Events (AEs)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary outcome [5] 0 0
The Number of Participants Experiencing Serious Adverse Events (SAEs)
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary outcome [6] 0 0
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary outcome [7] 0 0
The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
Secondary outcome [8] 0 0
The Number of Participants Deaths
Assessment method [8] 0 0
The number of participants that have died during the study.
Timepoint [8] 0 0
From first dose up to approximately 8 months
Secondary outcome [9] 0 0
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
Assessment method [9] 0 0
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
Timepoint [9] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary outcome [10] 0 0
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
Assessment method [10] 0 0
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
Timepoint [10] 0 0
From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2021
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Local Institution - 0005 - Elizabeth Vale
Recruitment hospital [2] 0 0
Breast Cancer Research Centre - WA - Nedlands
Recruitment postcode(s) [1] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Antwerpen
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Belgium
State/province [9] 0 0
Namur
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
France
State/province [11] 0 0
Bordeaux
Country [12] 0 0
France
State/province [12] 0 0
Creteil Cedex
Country [13] 0 0
France
State/province [13] 0 0
La Roche-sur-yon Cedex 9
Country [14] 0 0
France
State/province [14] 0 0
Lyon Cedex 08
Country [15] 0 0
France
State/province [15] 0 0
Marseille Cedex 9
Country [16] 0 0
France
State/province [16] 0 0
Montpellier
Country [17] 0 0
France
State/province [17] 0 0
TOULOUSE Cedex 9
Country [18] 0 0
Germany
State/province [18] 0 0
Bonn
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Moenchengladbach
Country [22] 0 0
Germany
State/province [22] 0 0
Saarbruecken
Country [23] 0 0
Puerto Rico
State/province [23] 0 0
Monterrey Ponce
Country [24] 0 0
Puerto Rico
State/province [24] 0 0
San Juan
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Malaga
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
Spain
State/province [29] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04075604