Actively Recruiting
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-05-20
27
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Cadonilimab combined with chemotherapy as a first or second-line treatment for patients with recurrent or metastatic triple-negative breast cancer (TNBC). TNBC has poor prognosis and limited treatment options. This phase II, open-label, non-randomized study aims to enroll 27 patients to better understand how this combination therapy works compared to chemotherapy alone, addressing limitations caused by toxicities in previous antibody combinations targeting CTLA-4 and PD-1 pathways. Participants will receive Cadonilimab at a dose of 10 mg/kg intravenously every three weeks along with chemotherapy, where the specific chemotherapy regimen is chosen by the treating physician. The study follows a Simon two-stage design and is conducted across multiple centers. This treatment period marks the first or second-line therapy for recurrent or metastatic TNBC, depending on prior chemotherapy timing. During the study, researchers will monitor patients for treatment response using objective response rate measures for up to two years. Safety assessments include tracking adverse events from consent signing through 90 days after the last dose. Participants will undergo evaluations of measurable lesions, performance status, and organ function. The total participation duration includes treatment and follow-up to assess both efficacy and safety outcomes.
CONDITIONS
Brief Title
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrent or metastatic triple-negative breast cancer (TNBC) patients
- TNBC defined by specific immunohistochemistry criteria including ER <1%, PR <1%, Her2=0~1+, or 2+ with no HER2 amplification by Fish test
- Received no or only first-line chemotherapy for recurrent or metastatic TNBC
- Age between 18 and 75 years at consent
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- Acceptable kidney and liver function
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Active central nervous system metastatic lesions or meningeal metastases
- Active autoimmune disease requiring systemic treatment within the past two years
- Known primary immunodeficiency
- Pregnant or breastfeeding women
- Any disease, treatment, or laboratory abnormalities that may affect study results or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive cadonilimab combined with chemotherapy as the active treatment for recurrent or metastatic triple negative breast cancer.
Intravenous treatment every 3 weeks
Duration - 90 days after last treatment dose
Participants are monitored for adverse events from the time of informed consent through 90 days after the last dose of drug.
Visits as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
J
Jie Xiong, PhD
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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