NCT05766410 (ORACLE-RIPA) is a Phase 2 clinical trial of Palbociclib in Breast Cancer, sponsored by National Taiwan University Hospital.

Who is sponsoring NCT05766410?

NCT05766410 is sponsored by National Taiwan University Hospital.

What drugs are being tested in NCT05766410?

Interventions in NCT05766410: Palbociclib, Ribociclib, Abemaciclib, Letrozole.

What condition does NCT05766410 study?

NCT05766410 studies Breast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Therapy.

Is NCT05766410 still recruiting?

NCT05766410 is currently recruiting now. Last updated 16 March 2023.

Last reviewed 2023-03-16 · How we verify

NCT05766410: ORACLE-RIPA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 2 Last updated 16 March 2023

What this trial tests

Phase 2 trial testing Palbociclib in Breast Cancer in 60 participants. Currently enrolling.

Timeline

16 September 2022

Primary endpoint
30 September 2025

30 September 2026

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	60
Start date	16 September 2022
Primary completion	30 September 2025
Estimated completion	30 September 2026
Sites	2 locations across Taiwan

Drugs / interventions tested

Palbociclib (Palbociclib) — full drug profile →
Ribociclib (ribociclib) — full drug profile →
Abemaciclib (abemaciclib) — full drug profile →
Letrozole — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Hormone Receptor-positive Breast Cancer — all drugs for Hormone Receptor-positive Breast Cancer →
Hormone Therapy — all drugs for Hormone Therapy →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, female only, with Breast Cancer or Hormone Receptor-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Autophagy and senescence facilitate the development of antiestrogen resistance in ER positive breast cancer.
McGrath MK, Abolhassani A, Guy L, Elshazly AM, et al · · 2024 · cited 10× · PMID 38567308 · DOI 10.3389/fendo.2024.1298423
Efficacy and Predictability of Cyclin-Dependent Kinase 4/6 Inhibitors in HER2-Positive Breast Cancer.
Abbasi MS, Afzal MZ, Sarwar T, Gamlen-Steves HA. · · 2025 · cited 1× · PMID 40940886 · DOI 10.3390/cancers17172788
The Dual Effects of CDK4/6 Inhibitors on Tumor Immunity.
Si Y, Li H, Shi Y. · · 2025 · PMID 41463246 · DOI 10.3390/cancers17243997
Alternate actions of CDK4/6 inhibitors beyond cell cycle blockade: unexplored roles in therapy resistance.
Scordamaglia D, Talia M, Zicarelli A, Mondino AA, et al · · 2025 · PMID 41388212 · DOI 10.1007/s10555-025-10307-w

Verify or expand the search:

Other trials of Palbociclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
NCT06997029 — A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors · Phase 1 · recruiting

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other National Taiwan University Hospital trials

Trials by the same sponsor.

NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05766410 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
Last refreshed: 16 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05766410.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing