RecruitingPhase 2NCT05766410

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

A Randomized, Open-label, Parallel-group Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in Early ER+/HER2- Breast Cancer

Sponsor

National Taiwan University Hospital

Enrollment

60 participants

Start Date

Sep 16, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Hormone Receptor-Positive Breast Cancer Hormone Therapy

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

Sex: FEMALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study compares three different CDK4/6 inhibitors — ribociclib, palbociclib, and abemaciclib — to see how each one affects the immune system in women with early-stage hormone receptor-positive, HER2-negative breast cancer. **You may be eligible if...** - You are a woman aged 20 or older - You have been diagnosed with estrogen receptor-positive, HER2-negative breast cancer confirmed by biopsy - Your cancer is at stage II or III - You have adequate organ function - Your overall health status is good (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are a woman of childbearing age who is unable or unwilling to use contraception - You have significant other health conditions that could interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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