A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
NCT ID: NCT04075604
Last Updated: 2022-08-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
23 participants
INTERVENTIONAL
2019-10-18
2021-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adjuvant Palbociclib in Elderly Patients With Breast Cancer
NCT03609047
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
NCT03650894
The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC
NCT04877821
Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC
NCT05969184
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
NCT07054190
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ)
Nivolumab
Specified Dose on Specified Days
Anastrozole
Specified Dose on Specified Days
Palbociclib
Specified Dose on Specified Days
Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ
Nivolumab
Specified Dose on Specified Days
Anastrozole
Specified Dose on Specified Days
Palbociclib
Specified Dose on Specified Days
Arm C: Palbociclib+ANZ
Anastrozole
Specified Dose on Specified Days
Palbociclib
Specified Dose on Specified Days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nivolumab
Specified Dose on Specified Days
Anastrozole
Specified Dose on Specified Days
Palbociclib
Specified Dose on Specified Days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0031
Whittier, California, United States
University Cancer Blood Ctr
Athens, Georgia, United States
Northside Hospital,Inc.- Central Research Department
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Local Institution - 0041
Florham Park, New Jersey, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Hematology-Oncology Associates Of Fredricksburg, Inc
Fredericksburg, Virginia, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Local Institution - 0005
Elizabeth Vale, South Australia, Australia
Breast Cancer Research Centre - WA
Nedlands, Western Australia, Australia
Local Institution - 0011
Wilrijk, Antwerpen, Belgium
Local Institution
Liège, , Belgium
Local Institution
Namur, , Belgium
Local Institution - 0071
Ottawa, Ontario, Canada
Local Institution - 0075
Bordeaux, , France
Local Institution - 0073
Créteil, , France
Local Institution - 0072
La Roche-sur-Yon, , France
Centre Leon Berard
Lyon, , France
Local Institution - 0019
Marseille, , France
Centre de Cancerologie du Grand Montpellier
Montpellier, , France
Institut Claudius Regaud
Toulouse, , France
Local Institution
Bonn, , Germany
Local Institution
Erlangen, , Germany
Klinik Essen-Mitte
Essen, , Germany
Local Institution
Mönchengladbach, , Germany
Local Institution
Saarbrücken, , Germany
Local Institution - 0047
Monterrey Ponce, , Puerto Rico
Local Institution - 0002
San Juan, , Puerto Rico
Local Institution - 0062
San Juan, , Puerto Rico
H. Univ. Vall dHebron
Barcelona, , Spain
Local Institution - 0037
Barcelona, , Spain
Hosp Univer 12 De Octubre
Madrid, , Spain
Hospital Universitario Virgen De La Victoria
Málaga, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA209-7A8
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.