Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer

NCT ID: NCT06367088

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-04-30

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 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

Triple-negative Breast Cancer; Cadonilimab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

Cadonilimab

Intervention Type: DRUG

Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.

Interventions

Cadonilimab

Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.

Intervention Type: DRUG

Other Intervention Names

physician's choice of chemotherapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanxia Zhao, PhD

Role: STUDY_CHAIR

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

Locations

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

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Xiong, PhD

Role: CONTACT

xxiongjie2000@163.com

+86-15927611872

Facility Contacts

Jie Xiong

Role: primary

xxiongjie2000@163.com

+8615927611872

Other Identifiers

Sophia

Identifier Type: -

Identifier Source: org_study_id