NCT06556862 is a Phase 2 clinical trial of Dalpiciclib in HR+/HER2- Advanced Breast Cancer, sponsored by Beijing 302 Hospital.

Who is sponsoring NCT06556862?

NCT06556862 is sponsored by Beijing 302 Hospital.

What drugs are being tested in NCT06556862?

Interventions in NCT06556862: Dalpiciclib, Chidamide, Enitinostat.

What condition does NCT06556862 study?

NCT06556862 studies HR+/HER2- Advanced Breast Cancer.

Is NCT06556862 still recruiting?

NCT06556862 is currently not yet recruiting. Last updated 13 August 2025.

Last reviewed 2025-08-13 · How we verify

NCT06556862

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

Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor

Not yet recruiting Phase 2 Last updated 13 August 2025

What this trial tests

Phase 2 trial testing Dalpiciclib in HR+/HER2- Advanced Breast Cancer in 155 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
31 December 2026

31 December 2028

Quick facts

Lead sponsor	Beijing 302 Hospital
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	155
Start date	1 October 2025
Primary completion	31 December 2026
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

Dalpiciclib — full drug profile →
Chidamide — full drug profile →
Enitinostat — full drug profile →

Conditions studied

HR+/HER2- Advanced Breast Cancer — all drugs for HR+/HER2- Advanced Breast Cancer →

Sponsor

Beijing 302 Hospital

Who can join

18 and older, any sex, with HR+/HER2- Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.

Publications & conference data

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

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
Epigenetic Therapies in Endocrine-Related Cancers: Past Insights and Clinical Progress.
Varun D, Haque M, Jackson-Oxley J, Thompson R, et al · · 2025 · cited 1× · PMID 40805121 · DOI 10.3390/cancers17152418
Epigenetic modifications in cancer drug resistance: molecular mechanisms and therapeutic interventions.
Yang J, Zhang M, Zhong Y, Sun C, et al · · 2026 · PMID 42053742 · DOI 10.1186/s43556-026-00458-9
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 Dalpiciclib

Trials testing the same drug.

NCT07207070 — A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined Wit · Phase 3 · recruiting
NCT07492394 — Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer · Phase 2 · recruiting
NCT07179939 — Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study · Phase 2 · not yet recruiting
NCT06650748 — Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With o · Phase 2 · enrolling by invitation
NCT06711094 — Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC · NA · not yet recruiting

Other recruiting trials for HR+/HER2- Advanced Breast Cancer

Currently open trials in the same condition.

NCT05983107 — Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer · Phase 2 · recruiting

Other Beijing 302 Hospital trials

Trials by the same sponsor.

NCT07514832 — VA-CIG Regimen for Previously Untreated Acute Myeloid Leukemia: A Multicenter Prospective Single-Arm Trial · Phase 2 · recruiting
NCT07297173 — Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia · Phase 1 · recruiting
NCT07106658 — TEAS for Variceal Bleeding Endoscopy in Cirrhosis · NA · completed
NCT06926647 — A Real-World Study of Antiviral Therapy in Children With Chronic Hepatitis B · not yet recruiting
NCT06877507 — Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath · 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 NCT06556862 (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 Beijing 302 Hospital
Last refreshed: 13 August 2025

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/NCT06556862.

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