A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Sponsor
National Taiwan University Hospital
Study ID
NCT05766410
Phase
PHASE2
Status
Recruiting
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Conditions

  • Breast Cancer
  • Hormone Receptor-positive Breast Cancer
  • Hormone Therapy

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palbociclib — DRUG
    CDK4, 6 inhibitor
  • Ribociclib — DRUG
    CDK4, 6 inhibitor
  • Abemaciclib — DRUG
    CDK4, 6 inhibitor
  • Letrozole — DRUG
    Endocrine therapy

Study Details

The 3 FDA-approved CDK4, 6 inhibitors, palbociclib, ribociclib, and abemciclib, all provided progression-free survival benefits when combined with endocrine therapy in advanced ER+/HER2- breast cancer. But, not all of them provided overall survival benefit in the same setting. One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4, 6 inhibitors on tumor microenvironment and/ or immune system. However, there was no head-to-head comparison of the 3 CDK4, 6 inhibitors in the same study. Neoadjuvant therapy provides a window to obtain tissue samples before treatment, during treatment, and after treatment. We aim to compare the immune modulation effects of palbociclib, ribociclib, and abemaciclib with letrozole in neoadjuvant treatment for ER+/HER2- early breast cancer.

Key Dates

Start date
Sep 16, 2022
Status verified
Sep 2022
Primary completion
Sep 30, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Palbociclib/Letrozole
    CDK4, 6 inhibitor and endocrine therapy
  • Active Comparator: Ribociclib/Letrozole
    CDK4, 6 inhibitor and endocrine therapy
  • Active Comparator: Abemaciclib/Letrozole
    CDK4, 6 inhibitor and endocrine therapy

Primary Outcome Measure

The expression of immune-related signature change after different CDK4/6 inhibitor treatments by RNAseq [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts

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