Breast CancerPhase 2CheckMate 7A8NCT04075604
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A Phase 2 study testing Nivolumab, Anastrozole and Palbociclib in people with Breast Cancer and Cancer, run by Bristol-Myers Squibb at 36 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer
- What is being tested?
- Nivolumab, Anastrozole and Palbociclib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 18 Oct 2019to 27 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
United States9 sites
University Cancer Blood Ctr
Athens, Georgia, 30607
Northside Hospital,Inc.- Central Research Department
Atlanta, Georgia, 30342
Northwestern University
Chicago, Illinois, 60611
MetroHealth Medical Center
Cleveland, Ohio, 44109
Local Institution - 0041
Florham Park, New Jersey, 07932
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg, Virginia, 22408
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601
Peninsula Cancer Institute
Newport News, Virginia, 23601
Local Institution - 0031
Whittier, California, 90603
France7 sites
Local Institution - 0075
Bordeaux, 33077
Local Institution - 0073
Créteil, 94010
Local Institution - 0072
La Roche-sur-Yon, 85925
Centre Leon Berard
Lyon, 69373
Local Institution - 0019
Marseille, 13273
Centre de Cancerologie du Grand Montpellier
Montpellier, 34070
Institut Claudius Regaud
Toulouse, 31059
Spain6 sites
H. Univ. Vall dHebron
Barcelona, 08035
Local Institution - 0037
Barcelona, 08036
Hosp Univer 12 De Octubre
Madrid, 28041
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Clinico Universitario De Valencia
Valencia, 46010
Germany5 sites
Local Institution
Bonn, 53111
Local Institution
Erlangen, 91054
Klinik Essen-Mitte
Essen, 45136
Local Institution
Mönchengladbach, 41061
Local Institution
Saarbrücken, 66113
Belgium3 sites
Local Institution
Liège, 4000
Local Institution
Namur, 5000
Local Institution - 0011
Wilrijk, Antwerpen, 2610
Puerto Rico3 sites
Local Institution - 0047
Monterrey Ponce, 00731
Local Institution - 0002
San Juan, 00927
Local Institution - 0062
San Juan, 00936
Australia2 sites
Local Institution - 0005
Elizabeth Vale, South Australia, 5112
Breast Cancer Research Centre - WA
Nedlands, Western Australia, 6009
About this study
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
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
- Conditions
- Breast Cancer, Cancer
- Being tested
- Nivolumab, Anastrozole, Palbociclib
- Keywords
- Nivolumab, Breast Cancer, Cancer, ER+, HER2-, Neoadjuvant
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Specified Dose on Specified Days
AnastrozoleDrug
Specified Dose on Specified Days
PalbociclibDrug
Specified Dose on Specified Days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) | Experimental | Not described Receives: Biological: Nivolumab; Drug: Anastrozole; Drug: Palbociclib |
| Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ | Experimental | Not described Receives: Biological: Nivolumab; Drug: Anastrozole; Drug: Palbociclib |
| Arm C: Palbociclib+ANZ | Active comparator | Not described Receives: Drug: Anastrozole; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
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.
Measured: From first dose to 4 weeks after first dose
Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
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.
Measured: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
Secondary outcomes (10)
Objective Response Rate (ORR)
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.
Measured: From first dose up to approximately 6 months after first dose
Breast Conserving Surgery (BCS) Rate
The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method.
Measured: From first dose up to approximately 6 months after first dose
Pathological Complete Response (pCR) Rate
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.
Measured: From first dose up to approximately 6 months after first dose
The Number of Participants Experiencing Adverse Events (AEs)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
The Number of Participants Deaths
The number of participants that have died during the study.
Measured: From first dose up to approximately 8 months
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
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
Measured: 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
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
Measured: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start18 Oct 2019
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075604
- Sponsor's protocol ID
- CA209-7A8
- Acronym
- CheckMate 7A8
- Status last verified
- Jul 2022
- First submitted
- 29 Aug 2019
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04075604
- Acronym / sponsor ID
- CheckMate 7A8 / CA209-7A8
- Conditions
- Breast Cancer, Cancer
- Keywords
- Nivolumab, Breast Cancer, Cancer, ER+, HER2-, Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) | Experimental | Biological: Nivolumab, Drug: Anastrozole, Drug: Palbociclib |
| Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ | Experimental | Biological: Nivolumab, Drug: Anastrozole, Drug: Palbociclib |
| Arm C: Palbociclib+ANZ | Active comparator | Drug: Anastrozole, Drug: Palbociclib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabSpecified Dose on Specified Days | Biological | Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ), Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ |
| AnastrozoleSpecified Dose on Specified Days | Drug | Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ), Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ, Arm C: Palbociclib+ANZ |
| PalbociclibSpecified Dose on Specified Days | Drug | Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ), Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ, Arm C: Palbociclib+ANZ |
Primary outcome
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.
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.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: 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
Pathological Complete Response (pCR) Rate
Time frame: 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 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 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 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 Deaths
Time frame: 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 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab, Anastrozole and Palbociclib in people with Breast Cancer and Cancer, run by Bristol-Myers Squibb at 36 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Spain, Germany, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.