Clinical trial NCT04075604: A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Cancer
Keywords: Nivolumab
Breast Cancer
Cancer
ER+
HER2-
Neoadjuvant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase
timeFrame: From first dose to 4 weeks after first dose
measure: Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase
timeFrame: From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose up to approximately 6 months after first dose
measure: Breast Conserving Surgery (BCS) Rate
timeFrame: From first dose up to approximately 6 months after first dose
measure: Pathological Complete Response (pCR) Rate
timeFrame: From first dose up to approximately 6 months after first dose
measure: The Number of Participants Experiencing Adverse Events (AEs)
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
measure: The Number of Participants Experiencing Serious Adverse Events (SAEs)
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
measure: The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
measure: The Number of Participants Experiencing Immune-Related Adverse Events (AEs)
timeFrame: From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
measure: The Number of Participants Deaths
timeFrame: From first dose up to approximately 8 months
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
measure: The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests
timeFrame: From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Other outcomes:
Locations:
city: Whittier
country: United States
facility: Local Institution - 0031
state: California
city: Athens
country: United States
facility: University Cancer Blood Ctr
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital,Inc.- Central Research Department
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Florham Park
country: United States
facility: Local Institution - 0041
state: New Jersey
city: Hackensack
country: United States
facility: The Cancer Center At Hackensack University Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Fredericksburg
country: United States
facility: Hematology-Oncology Associates Of Fredricksburg, Inc
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Elizabeth Vale
country: Australia
facility: Local Institution - 0005
state: South Australia
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre - WA
state: Western Australia
city: Wilrijk
country: Belgium
facility: Local Institution - 0011
state: Antwerpen
city: Liege
country: Belgium
facility: Local Institution
city: Namur
country: Belgium
facility: Local Institution
city: Ottawa
country: Canada
facility: Local Institution - 0071
state: Ontario
city: Bordeaux
country: France
facility: Local Institution - 0075
city: Creteil Cedex
country: France
facility: Local Institution - 0073
city: La Roche-sur-yon Cedex 9
country: France
facility: Local Institution - 0072
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Marseille Cedex 9
country: France
facility: Local Institution - 0019
city: Montpellier
country: France
facility: Centre de Cancerologie du Grand Montpellier
city: TOULOUSE Cedex 9
country: France
facility: Institut Claudius Regaud
city: Bonn
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Klinik Essen-Mitte
city: Moenchengladbach
country: Germany
facility: Local Institution
city: Saarbruecken
country: Germany
facility: Local Institution
city: Monterrey Ponce
country: Puerto Rico
facility: Local Institution - 0047
city: San Juan
country: Puerto Rico
facility: Local Institution - 0002
city: San Juan
country: Puerto Rico
facility: Local Institution - 0062
city: Barcelona
country: Spain
facility: H. Univ. Vall dHebron
city: Barcelona
country: Spain
facility: Local Institution - 0037
city: Madrid
country: Spain
facility: Hosp Univer 12 De Octubre
city: Malaga
country: Spain
facility: Hospital Universitario Virgen De La Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico Universitario De Valencia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: