Actively Recruiting
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
Led by QIAO LI · Updated on 2025-05-02
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients fully understand and voluntarily participate in this study and sign the informed consent form.
- Age 18 to 75 years.
- Newly diagnosed triple-negative breast cancer with stage T1c N1-3 or T2-4 N0-3.
- Patients scheduled to receive neoadjuvant therapy.
- Patients have measurable lesions (non-lymph node lesions 10 mm or longer and lymph node lesions 15 mm or longer as per RECIST 1.1).
- No previous antitumor systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients voluntarily joined the study with good compliance.
- Good organ function with specific blood counts and liver, kidney, and coagulation parameters within defined limits, and no blood transfusion or growth factor support within 2 weeks before first trial medication dose.
You will not qualify if you...
- Pathological diagnosis of hormone receptor-positive or HER2-positive breast cancer.
- Imaging shows metastatic breast cancer.
- Previous or current concurrent malignancy other than breast cancer.
- Any active autoimmune disease or history of autoimmune diseases such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary vasculitis, nephritis, hyperthyroidism, vitiligo; asthma requiring medical intervention is excluded.
- Use of immunosuppressants or systemic hormone therapy (prednisone dose >10 mg/day or equivalent) continued within 2 weeks prior to enrollment.
- Recurrence after surgery or previous local or systemic antitumor therapy.
- Known allergy to the study drug ingredients.
- Poorly controlled cardiac symptoms or diseases including NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within 1 year, or significant arrhythmias requiring treatment.
- Active infection or unexplained fever above 38.5°C during screening or before initial treatment (tumor-related fever allowed).
- Live vaccine administered less than 4 weeks before or possibly during the study.
- History of psychotropic substance abuse, alcohol abuse, or drug use.
- Other severe medical conditions or social factors that may affect safety or data collection as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, China, 100021
Actively Recruiting
Research Team
B
Binghe Xu
CONTACT
Q
Qiao Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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