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

NCT04075604

Description:

A randomized multi-arm study evaluating the safety and efficacy of abemaciclib or palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Neoadjuvant Nivolumab + Abemaciclib or 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 + Abemaciclib or Palbociclib + Anastrozole

Clinical Trial IDs

  • ORG STUDY ID: CA209-7A8
  • NCT ID: NCT04075604

Conditions

  • Breast Cancer
  • Cancer

Interventions

DrugSynonymsArms
NivolumabArm A: Nivolumab +Abemaciclib+Anastrozole (ANZ)
AbemaciclibArm A: Nivolumab +Abemaciclib+Anastrozole (ANZ)
AnastrozoleArm A: Nivolumab +Abemaciclib+Anastrozole (ANZ)
PalbociclibArm D: Nivolumab+Palbociclib+ANZ

Purpose

A randomized multi-arm study evaluating the safety and efficacy of abemaciclib or palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

Trial Arms

NameTypeDescriptionInterventions
Arm A: Nivolumab +Abemaciclib+Anastrozole (ANZ)Experimental
  • Nivolumab
  • Abemaciclib
  • Anastrozole
Arm B: Abemaciclib+ANZ then Nivolumab+Abemaciclib+ANZExperimental
  • Nivolumab
  • Abemaciclib
  • Anastrozole
Arm C: Abemaciclib+ANZActive Comparator
  • Abemaciclib
  • Anastrozole
Arm D: Nivolumab+Palbociclib+ANZExperimental
  • Nivolumab
  • Anastrozole
  • Palbociclib
Arm E: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZExperimental
  • Nivolumab
  • Anastrozole
  • Palbociclib
Arm F: Palbociclib+ANZActive Comparator
  • Anastrozole
  • Palbociclib

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.

          -  ECOG <=1.

        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 co-stimulation or checkpoint pathways, or history of
             allergy, or hypersensitivity to study drug components

          -  Prior Malignancy active within the previous 3 years as well as 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 inclusion/exclusion criteria apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity
Time Frame:up to 4 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:up to 34 weeks
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAE)
Time Frame:up to 34 weeks
Safety Issue:
Description:
Measure:AEs leading to Discontinuation
Time Frame:up to 34 weeks
Safety Issue:
Description:
Measure:Immune-related AEs
Time Frame:up to 34 weeks
Safety Issue:
Description:
Measure:Number of laboratory abnormalities
Time Frame:up to 34 weeks
Safety Issue:
Description:
Measure:Pathological Complete Response (pCR) by local assessment
Time Frame:up to 20 weeks
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:up to 20 weeks
Safety Issue:
Description:
Measure:Breast Conserving Surgery (BCS) rate
Time Frame:up to 20 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • Nivolumab
  • Breast Cancer
  • Cancer
  • ER+
  • HER2-
  • Neoadjuvant

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