A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

Breast Cancer Clinical Trial

— CheckMate 7A8  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075604
• Other study ID #: CA209-7A8
• Status: Completed
• Phase: Phase 2
• Start date: October 18, 2019
• Est. completion date: July 27, 2021

Study information

• Verified date: July 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 27, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer

Intervention

Biological:
• Nivolumab
Specified Dose on Specified Days

Drug:
• Anastrozole
Specified Dose on Specified Days
• Palbociclib
Specified Dose on Specified Days

Locations

Country	Name	City	State
Australia	Local Institution - 0005	Elizabeth Vale	South Australia
Australia	Breast Cancer Research Centre - WA	Nedlands	Western Australia
Belgium	Local Institution	Liege
Belgium	Local Institution	Namur
Belgium	Local Institution - 0011	Wilrijk	Antwerpen
Canada	Local Institution - 0071	Ottawa	Ontario
France	Local Institution - 0075	Bordeaux
France	Local Institution - 0073	Creteil Cedex
France	Local Institution - 0072	La Roche-sur-yon Cedex 9
France	Centre Leon Berard	Lyon Cedex 08
France	Local Institution - 0019	Marseille Cedex 9
France	Centre de Cancerologie du Grand Montpellier	Montpellier
France	Institut Claudius Regaud	TOULOUSE Cedex 9
Germany	Local Institution	Bonn
Germany	Local Institution	Erlangen
Germany	Klinik Essen-Mitte	Essen
Germany	Local Institution	Moenchengladbach
Germany	Local Institution	Saarbruecken
Puerto Rico	Local Institution - 0047	Monterrey Ponce
Puerto Rico	Local Institution - 0002	San Juan
Puerto Rico	Local Institution - 0062	San Juan
Spain	H. Univ. Vall dHebron	Barcelona
Spain	Local Institution - 0037	Barcelona
Spain	Hosp Univer 12 De Octubre	Madrid
Spain	Hospital Universitario Virgen De La Victoria	Malaga
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Clinico Universitario De Valencia	Valencia
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	MetroHealth Medical Center	Cleveland	Ohio
United States	Local Institution - 0041	Florham Park	New Jersey
United States	Hematology-Oncology Associates Of Fredricksburg, Inc	Fredericksburg	Virginia
United States	The Cancer Center At Hackensack University Medical Center	Hackensack	New Jersey
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Local Institution - 0031	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose to 4 weeks after first dose
Primary	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.	From randomization phase up to 5 treatment cycles (up to approximately 20 weeks)
Secondary	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.	From first dose up to approximately 6 months after first dose
Secondary	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.	From first dose up to approximately 6 months after first dose
Secondary	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.	From first dose up to approximately 6 months after first dose
Secondary	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.	From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary	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.	From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary	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.	From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary	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.	From first dose to 100 days after last dose of study therapy (up to approximately 8 months)
Secondary	The Number of Participants Deaths	The number of participants that have died during the study.	From first dose up to approximately 8 months
Secondary	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	From first dose to 30 days after last dose of study therapy (up to approximately 6 months)
Secondary	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	From first dose to 30 days after last dose of study therapy (up to approximately 6 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls