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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT06955156 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage T1C N1-3 or T2-4 N0-3 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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