NCT06612814 is a Phase 3 clinical trial of Fluzoparib in Breast Cancer Metastatic, sponsored by Zhimin Shao.

Who is sponsoring NCT06612814?

NCT06612814 is sponsored by Zhimin Shao.

What drugs are being tested in NCT06612814?

Interventions in NCT06612814: Fluzoparib, Dalpiciclib, Fulvestrant/AI.

What condition does NCT06612814 study?

NCT06612814 studies Breast Cancer Metastatic.

Is NCT06612814 still recruiting?

NCT06612814 is currently active, enrolled. Last updated 25 September 2024.

Last reviewed 2024-09-25 · How we verify

NCT06612814

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

PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

Active, enrolled Phase 3 Last updated 25 September 2024

What this trial tests

Phase 3 trial testing Fluzoparib in Breast Cancer Metastatic in 307 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 September 2024

Primary endpoint
30 October 2027

30 April 2028

Quick facts

Lead sponsor	Zhimin Shao
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	307
Start date	1 September 2024
Primary completion	30 October 2027
Estimated completion	30 April 2028
Sites	1 location across China

Drugs / interventions tested

Fluzoparib — full drug profile →
Dalpiciclib — full drug profile →
Fulvestrant/AI — full drug profile →

Conditions studied

Breast Cancer Metastatic — all drugs for Breast Cancer Metastatic →

Sponsor

Zhimin Shao — full company profile →

Who can join

Adults 18 to 75, female only, with Breast Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, open-label, phase III clinical study for patients with HR+/HER2- advanced breast cancer.

Publications & conference data

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

Clinical approaches to overcome PARP inhibitor resistance.
Zou Y, Zhang H, Chen P, Tang J, et al · · 2025 · cited 32× · PMID 40442774 · DOI 10.1186/s12943-025-02355-1
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
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 Fluzoparib

Trials testing the same drug.

NCT07353437 — Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast · Phase 2 · not yet recruiting
NCT07382713 — Fluzoparib Plus Famitinib Maintenance After First-Line Platinum Response in Advanced Ovarian Cancer · Phase 2 · not yet recruiting
NCT07141771 — An Umbrella Study of Recurrent, Extensive Stage Small Cell Lung Cancer Based on Molecular Typing · Phase 1, PHASE2 · not yet recruiting
NCT06735326 — Fluzoparib With or Without Bevacizumab for Neoadjuvant Therapy in Advanced Ovarian Cancer · Phase 2 · recruiting
NCT06539091 — Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Breast Cancer Metastatic

Currently open trials in the same condition.

NCT07292168 — A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Ex · Phase 1, PHASE2 · recruiting
NCT06616987 — Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer · Phase 2 · recruiting
NCT06750484 — Trial of Trastuzumab Deruxtecan in Previously Treated HER2 · Phase 2 · recruiting
NCT06784921 — To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Pa · recruiting
NCT07154563 — Rapid Assessment of Sentinel Lymph Node Metastasis Status Using a Pan-CK-targeting NIR-II Fluorescent Probe in Breast Ca · recruiting

Other Zhimin Shao trials

Trials by the same sponsor.

NCT07245797 — A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plu · Phase 2 · not yet recruiting
NCT03507088 — Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive M · NA · completed

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 NCT06612814 (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 Zhimin Shao
Last refreshed: 25 September 2024

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/NCT06612814.

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