Status:
RECRUITING
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Triple-negative Breast Cancer
Cadonilimab
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 antib...
Eligibility Criteria
Inclusion Criteria:
- Recurrent or metastatic TNBC patients;
- TNBC defined by immunohistochemistry as ER<1%, PR<1%, Her2=0~1+, or 2+ while HER2 Fish test shows no amplification;
- Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC;When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment;
- ages 18 to 75 years at the time of signing the informed consent form (ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
- expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1);
- acceptable renal and liver function;
Exclusion Criteria:
- They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.);
- Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases;
- Patients with an active autoimmune disease that requires systemic treatment in the past two years;
- A known history of primary immunodeficiency;
- Pregnant or lactating women;
- Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06367088
Start Date
May 1 2024
End Date
April 30 2027
Last Update
May 20 2025
Active Locations (1)
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1
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022