Trilaciclib with chemotherapy for advanced triple negative breast cancer

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

This study is testing if a new drug called Trilaciclib can help protect the bone marrow of patients with advanced triple negative breast cancer while they receive chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: prednisone, chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06955156 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Trilaciclib, a CDK4/6 inhibitor, in combination with an anti-PD-1 antibody and chemotherapy for patients with locally advanced triple negative breast cancer (TNBC). The study aims to protect bone marrow and hematopoietic stem cells during chemotherapy, potentially reducing adverse effects like myelosuppression. It is an open-label, single-arm Phase II trial that will enroll 50 newly diagnosed TNBC patients who meet specific inclusion criteria. Participants will receive neoadjuvant therapy to evaluate the synergistic effects of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed stage T1c N1-3 or T2-4 N0-3 TNBC scheduled for neoadjuvant therapy.

Not a fit: Patients with prior antitumor therapy or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the effectiveness of chemotherapy while minimizing harmful side effects for patients with TNBC.

How similar studies have performed: While the specific combination of Trilaciclib with anti-PD-1 and chemotherapy is novel, similar approaches using CDK inhibitors have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Patients fully understand and voluntarily participate in this study and sign the informed consent form.
2. Age ≥18 and ≤75 years.
3. Newly diagnosed TNBC with stage T1c N1-3 or stage T2-4 N0-3.
4. Patients scheduled to receive neoadjuvant therapy.
5. Patients have measurable lesions (non-lymph node lesions ≥10 mm in length and lymph node lesions ≥15 mm in length according to RECIST 1.1 standards).
6. No previous antitumor system therapy.
7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
8. Patients voluntarily joined the study with nice compliance.
9. Good organ function (no blood transfusion or growth factor support within 2 weeks before the first dose of trial medication): WBC≥3.0×10\^9/L, ANC ≥1.5×10\^9/L, PLT ≥75×10\^9/L, Hb≥90g/L, ALP≤5×ULN, ALT≤3×ULN, AST≤3×ULN, ALB≥28 g/L, Creatinine≤1.5×ULN or Creatinine clearance ≥50 mL/min, INR≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN (If patient is receiving anticoagulant therapy, as long as the PT INR is within the prescribed range of anticoagulants).

Exclusion Criteria:

1. Pathological diagnosis of HR+ or HER2+ breast cancer.
2. Imaging shows metastatic breast cancer.
3. Previous or current concurrent malignancy other than breast cancer.
4. Patients had any active autoimmune disease or a history of autoimmune disease (e.g., but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary vasculitis, nephritis, hyperthyroidism; Patients had vitiligo; Patients who had complete remission of asthma in childhood and without any intervention in adulthood were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
5. Patients are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \> 10mg/day of prednisone or other therapeutic hormone) and continued use within 2 weeks prior to enrollment.
6. Recurrence after surgery, previous local or systemic antitumor therapy.
7. Patients are known to have a prior allergy to the drug ingredient being applied.
8. Patients with poorly controlled cardiac clinical symptoms or diseases, such as (1)NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
9. Patients with active infection or unexplained fever during screening or prior to initial treatment \>38.5℃ (as determined by the investigator, the subject's fever due to the tumor can be enrolled).
10. Live vaccine was administered less than 4 weeks before or possibly during the study period
11. Patients have a known history of psychotropic substance abuse, alcohol abuse, or druggy use.
12. Patients should be excluded if, in the investigator's judgment, the subjects have other factors that may cause the study to be terminated (other severe medical conditions requiring concomitant treatment, serious laboratory abnormalities, associated family or social factors, and other circumstances that may affect the safety of the subjects or the collection of data and samples).

Where this trial is running

Beijing

• National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Qiao Li — National Cancer Center/Cancer Hospital
• Study coordinator: Binghe Xu

Conditions Triple Negative Breast Cancer