A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
Completed · Phase 2
Conditions studied: Breast Cancer, Cancer
In brief
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
Key facts
- Study ID
- NCT04075604
- Run by
- Bristol-Myers Squibb
- People needed
- 23
- Starts
- 2019-10-18
- Expected to finish
- 2021-07-27
- Last updated by the study team
- 2022-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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