RecruitingPhase 2NCT06955156

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

Trilaciclib in Combination With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced Triple-negative Breast Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Study


Sponsor

QIAO LI

Enrollment

50 participants

Start Date

Jul 3, 2023

Study Type

INTERVENTIONAL

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called trilaciclib — which temporarily protects bone marrow during chemotherapy — to a standard combination of immunotherapy and chemotherapy improves outcomes and reduces side effects in people with newly diagnosed triple-negative breast cancer (TNBC). The treatment is given before surgery (neoadjuvant therapy) to shrink the tumor. **You may be eligible if...** - You are between 18 and 75 years old with newly diagnosed triple-negative breast cancer (stage T1c N1-3 or T2-4 N0-3) - You are scheduled to receive pre-surgical (neoadjuvant) chemotherapy - You have not received any prior cancer drug treatment - You have good organ function and performance status **You may NOT be eligible if...** - Your breast cancer is hormone receptor-positive (HR+) or HER2-positive - Imaging shows your cancer has already spread to distant organs (metastatic) - You have an active autoimmune disease or a history of one (with some exceptions) - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrilaciclib

trilaciclib 240mg/m2 ivgtt d1 Q3w; anti-PD-1 antibody 200mg ivgtt d1 Q3w; Paclitaxel-albumin 250mg/m2 ivgtt d1 Q3w or 125mg/m2 ivgtt d1,d8 Q3w; carboplatin AUC=5 ivgtt d1 Q3w; Review every 2 cycles until the best efficacy or intolerable toxicity, usually 6-8 cycles;


Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, China

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NCT06955156