RecruitingPhase IIFemale onlyEN original

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta w wieku co najmniej 20 lat
  • Potwierdzony nowotwór piersi wrażliwy na hormony (receptor estrogenowy i/lub progesteronowy dodatni)
  • Zaawansowanie raka II lub III stopnia
  • Prawidłowe funkcjonowanie organów wewnętrznych
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-1)

✗ Disqualifies

  • Kobieta w ciąży lub karmiąca piersią
  • Kobieta w wieku rozrodczym bez stosowania skutecznej antykoncepcji przez czas badania i 12 miesięcy po jego zakończeniu
  • Aktywne infekcje, AIDS lub dodatni test HIV
  • Inne choroby lub stany, które mogłyby utrudnić udział w badaniu lub współpracę

Simplified criteria — AI translation

Trial details

Minimum age
20 Years
Last updated (source)
March 16, 2023
Sex
Female only

Therapies / drugs in trial

Locations (2)

Department of Oncology, National Taiwan University Hospital

Taipei, Taiwan

Department of Oncology,National Taiwan University Hospital

Taipei, Taiwan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.