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

Last updated: March 15, 2023
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Breast Cancer

Cancer Treatment

Treatment

N/A

Clinical Study ID

NCT05766410
202207200MIPB
  • Ages > 20
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female patients aged ≥ 20 years old at the time of informed consent.
  • Patient has a histologically and/or cytologically confirmed diagnosis ofestrogen-receptor positive and/or progesterone receptor positive breast cancer basedon the most recently analyzed tissue sample and all tested by local laboratory. withestrogen receptor positive (>10%) on IHC staining and HER2 negative (IHC 0+/1+, or IHC 2+ plus FISH negative)
  • Stage II to III
  • With adequate organ function
  • ECOG 0-1

Exclusion

Exclusion Criteria:

  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless using highly effective methods ofcontraception during study drug dosing and for 12 months post-dosing
  • Patients with active systemic infections or known to have AIDS or to test positive forHIV antibody at Screening
  • Any other disease or condition that could interfere with participation in the studyaccording to the study protocol, or with the ability of the patients to cooperate andcomply with the study procedures.

Study Design

Total Participants: 60
Study Start date:
September 16, 2022
Estimated Completion Date:
September 30, 2026

Study Description

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. We will collect tumor tissue, blood, and stool samples prospectively before treatment, at 2 weeks after treatment, and after 12 weeks of treatment at the time of surgery. Immune modulation effects will be compared between 3 treatment groups from breast tumor RNAseq analysis.

Connect with a study center

  • Department of Oncology,National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Department of Oncology, National Taiwan University Hospital

    Taipei City, 100
    Taiwan

    Active - Recruiting

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