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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.
CONDITIONS
Official 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 immunohistochemistry as ER<1%, PR<1%, Her2=0~1+, or 2+ with no HER2 amplification by Fish test
- No prior chemotherapy or only first-line chemotherapy for recurrent or metastatic TNBC
- Ages 18 to 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 version 1.1
- Acceptable kidney and liver function
You will not qualify if you...
- Previous treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies)
- Active central nervous system metastatic lesions or meningeal metastases
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Known primary immunodeficiency
- Pregnant or breastfeeding women
- Any current or past abnormalities in disease, treatment, or lab tests that could affect study results or participation
AI-Screening
AI-Powered Screening
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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
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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