OncoMatch/Clinical Trials/NCT05766410
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
Is NCT05766410 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Palbociclib and Ribociclib for breast cancer.
Treatment: Palbociclib · Ribociclib · Abemaciclib · Letrozole — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 estrogen receptor positive (>10% on IHC) (>10% on IHC)
estrogen receptor positive (>10%) on IHC staining
Required: HER2 (ERBB2) negative (IHC 0+/1+, or IHC 2+ plus FISH negative) (IHC 0+/1+, or IHC 2+ plus FISH negative)
HER2 negative (IHC 0+/1+, or IHC 2+ plus FISH negative)
Required: PR (PGR) progesterone receptor positive
progesterone receptor positive breast cancer
Disease stage
Required: Stage II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Kidney function
Liver function
With adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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