OncoMatch/Clinical Trials/NCT06955156
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
Is NCT06955156 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trilaciclib for triple negative breast cancer.
Treatment: Trilaciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (negative)
Pathological diagnosis of HR+ ... breast cancer [excluded]
Required: PR (PGR) overexpression (negative)
Pathological diagnosis of HR+ ... breast cancer [excluded]
Required: HER2 (ERBB2) overexpression (negative)
Pathological diagnosis of ... HER2+ breast cancer [excluded]
Disease stage
Required: Stage T1C N1-3, T2-4 N0-3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumor systemic therapy
No previous antitumor system therapy
Cannot have received: local or systemic antitumor therapy
Recurrence after surgery, previous local or systemic antitumor therapy
Lab requirements
Blood counts
wbc≥3.0×10^9/l, anc ≥1.5×10^9/l, plt ≥75×10^9/l, hb≥90g/l
Kidney function
creatinine≤1.5×uln or creatinine clearance ≥50 ml/min
Liver function
alp≤5×uln, alt≤3×uln, ast≤3×uln, alb≥28 g/l
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify