ER+/HER2- Breast Cancer MedDRA version: 21.1 Level: PT Classification code 10070577 Term: Oestrogen receptor positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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. - ECOG =65 years) yes F.1.3.1 Number of subjects for this age range 163
Exclusion criteria
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 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 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 costimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components - Prior Malignancy active within the previous 3 years as well as 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 exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Run-in Phase: Number of participants with occurrence of DLT. Randomized Phase: To assess RCB 0-I rate by central assessment of abemaciclib or palbociclib plus anastrozole with or without nivolumab in all participants with untreated primary BC equal or more to 2 cm (ER+, HER2-).;Secondary Objective: To assess the safety and tolerability of abemaciclib or palbociclib plus anastrozole with or without nivolumab To assess pCR rate by local assessment of abemaciclib or palbociclib plus anastrozole with or without nivolumab in participants with untreated primary BC equal or more to 2 cm (ER+, HER2-). To assess ORR (clinical and radiological [ultrasound (preferred) or mammography]) by Investigator assessment and BCS rate of abemaciclib or palbociclib plus anastrozole with or without nivolumab in participants with untreated primary BC equal or more to 2 cm (ER+, HER2-).;Primary end point(s): 1) Dose Limiting Toxicity 2) Residual Cancer Burden (RCB) 0-1 rate by central assessment;Timepoint(s) of evaluation of this end point: 1) up to 4 weeks 2) up to 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3) Incidence of Adverse Events (AEs) 4) Incidence of Serious Adverse Events (SAE) 5) AEs leading to Discontinuation 5) Immune-related AEs 6) Number of laboratory abnormalities 7) Pathological Complete Response (pCR) by local assessment 8) Objective Response Rate (ORR) 9) Breast Conserving Surgery (BCS) rate;Timepoint(s) of evaluation of this end point: 3) to 7): Up to 34 weeks 8- to 10): Up to 20 weeks | — |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Spain
Contacts
Public ContactHead of the GCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed