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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
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
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)
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
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
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)
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)
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
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)
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
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
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
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
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT04075604
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04075604