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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.

Phase 2RecruitingNational Taiwan University HospitalNCT05766410Data as of May 2026

Treatment: Palbociclib · Ribociclib · Abemaciclib · LetrozoleThe 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.

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Extracted 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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