NCT05586841 is a Phase 1 clinical trial of Dalpiciclib in HR+/HER2- Advanced Breast Cancer, sponsored by Beijing 302 Hospital.

Who is sponsoring NCT05586841?

NCT05586841 is sponsored by Beijing 302 Hospital.

What drugs are being tested in NCT05586841?

Interventions in NCT05586841: Dalpiciclib, Chidamide.

What condition does NCT05586841 study?

NCT05586841 studies HR+/HER2- Advanced Breast Cancer.

Is NCT05586841 still recruiting?

NCT05586841 is currently status unknown. Last updated 19 October 2022.

Last reviewed 2022-10-19 · How we verify

NCT05586841

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

Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study

Status unknown Phase 1 Last updated 19 October 2022

What this trial tests

Phase 1 trial testing Dalpiciclib in HR+/HER2- Advanced Breast Cancer in 30 participants. Status unknown.

Timeline

1 November 2022

Primary endpoint
30 November 2024

30 November 2025

Quick facts

Lead sponsor	Beijing 302 Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 November 2022
Primary completion	30 November 2024
Estimated completion	30 November 2025
Sites	1 location across China

Drugs / interventions tested

Dalpiciclib — full drug profile →
Chidamide — 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, female only, with HR+/HER2- Advanced Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A phase 1B study to explore the maximum tolerated dose (MTD) of dalpiciclib + chidamide in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy

Publications & conference data

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

Systematic review of the management of brain metastases from hormone receptor positive breast cancer.
Jusino S, Fadul CE, Dillon P. · · 2023 · cited 14× · PMID 36884200 · DOI 10.1007/s11060-023-04276-9
Unveiling the Potential of Cyclin-Dependent Kinases 4 and 6 Inhibitors Beyond Progression in Hormone Receptor Positive/Human Epidermal Growth Factor Negative Advanced Breast Cancer - A Clinical Review.
Benvenuti C, Grinda T, Rassy E, Dixon-Douglas J, et al · · 2024 · cited 4× · PMID 39614985 · DOI 10.1007/s11864-024-01259-4
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
Dalpiciclib plus chidamide in HR + /HER2-advanced breast cancer after CDK4/6 inhibitor failure: a phase Ib trial.
Zhou J, Wu X, Du Y, Xiao J, et al · · 2026 · PMID 41862468 · DOI 10.1038/s41467-026-70650-6
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
NCT06556862 — Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor · Phase 2 · not yet 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

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
NCT06556862 — Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor · Phase 2 · not yet 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

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 NCT05586841 (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: 19 October 2022

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/NCT05586841.

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