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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Page 1 of 1 (1 locations)

1

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022