NCT06955156 is a Phase 2 clinical trial of Trilaciclib in Triple Negative Breast Cancer, sponsored by QIAO LI.

Who is sponsoring NCT06955156?

NCT06955156 is sponsored by QIAO LI.

What drugs are being tested in NCT06955156?

Interventions in NCT06955156: Trilaciclib.

What condition does NCT06955156 study?

NCT06955156 studies Triple Negative Breast Cancer.

Is NCT06955156 still recruiting?

NCT06955156 is currently recruiting now. Last updated 2 May 2025.

Last reviewed 2025-05-02 · How we verify

NCT06955156

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

Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Recruiting now Phase 2 Last updated 2 May 2025

What this trial tests

Phase 2 trial testing Trilaciclib in Triple Negative Breast Cancer in 50 participants. Currently enrolling.

Timeline

3 July 2023

Primary endpoint
1 May 2025

1 July 2025

Quick facts

Lead sponsor	QIAO LI
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	3 July 2023
Primary completion	1 May 2025
Estimated completion	1 July 2025
Sites	1 location across China

Drugs / interventions tested

Trilaciclib — full drug profile →

Conditions studied

Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

QIAO LI

Who can join

Adults 18 to 75, any sex, with Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Trilaciclib is a highly potent, selective, and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.

Publications & conference data

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

Breast Cancer: Molecular Pathogenesis, Targeted Therapy, Screening, and Prevention.
Lei H, Fu J, Gu W, Qiao H, et al · · 2026 · PMID 41510186 · DOI 10.1002/mco2.70560
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 Trilaciclib

Trials testing the same drug.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT06714266 — Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell · Phase 2 · not yet recruiting
NCT06698965 — Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Tr · Phase 2 · recruiting
NCT06490081 — Trilaciclib Prevents Myelosuppression With Chemoradiotherapy · Phase 2 · recruiting
NCT06370416 — the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib · Phase 2 · enrolling by invitation

Other recruiting trials for Triple Negative Breast Cancer

Currently open trials in the same condition.

NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H · Phase 3 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer · Phase 1, PHASE2 · recruiting
NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE) · NA · recruiting

Other QIAO LI trials

Trials by the same sponsor.

NCT07117864 — Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER · NA · recruiting
NCT06857747 — Disitamab Vedotin in Combination with Metronomic Chemotherapy in Advanced HER2-expressing Breast Cancer. · NA · unknown

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 NCT06955156 (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 QIAO LI
Last refreshed: 2 May 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/NCT06955156.

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