Recruiting

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

ClinicalTrials.gov IDNCT05766410

PhasePHASE2

Enrollment60

SponsorNational Taiwan University Hospital

Age20 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy

About this study

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.

Interventions

Drug: Palbociclib — CDK4, 6 inhibitor
Drug: Ribociclib — CDK4, 6 inhibitor
Drug: Abemaciclib — CDK4, 6 inhibitor
Drug: Letrozole — Endocrine therapy

Primary outcomes

The expression of immune-related signature change after different CDK4/6 inhibitor treatments by RNAseq (Through study completion, an average of 3 years)

Eligibility information

Inclusion Criteria: * Female patients aged ≥ 20 years old at the time of informed consent. * Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. with estrogen 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 Criteria: * Pregnant or nursing (lactating) women * Women of child-bearing potential unless using highly effective methods of contraception during study drug dosing and for 12 months post-dosing * Patients with active systemic infections or known to have AIDS or to test positive for HIV antibody at Screening * Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.

Study locations

Department of Oncology, National Taiwan University Hospital, Taipei, 100 Taiwan
Department of Oncology,National Taiwan University Hospital, Taipei, 100 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.