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

NCT06367088 | Recruiting Phase 2 DMC

• 1 other identifier: Sophia
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

triple negative breast cancer; Cadonilimab; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

  Up to 2 years

Secondary Outcomes (1)

• AE

  From the time of informed consent signed through 90 days after the last dose of drug

Other Outcomes (3)

• Progression-free survival

  Up to 2 years

• Overall survival

  Up to 2 years

• Disease control rate

  Up to 2 years

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Drug: Cadonilimab

Interventions

Cadonilimab DRUG

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

Also known as: physician's choice of chemotherapy

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yanxia Zhao, PhD

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

  STUDY CHAIR

Central Study Contacts

Jie Xiong, PhD

CONTACT

+86-15927611872; xxiongjie2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)