Combining Cadonilimab with chemotherapy for treating advanced triple-negative breast cancer

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

This study is testing if combining a new antibody treatment called Cadonilimab with chemotherapy can help people with advanced triple-negative breast cancer feel better compared to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: chemotherapy, Cadonilimab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06367088 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, combined with chemotherapy for patients with recurrent or metastatic triple-negative breast cancer (TNBC). It is a multicenter, single-arm, phase II trial designed to enroll 27 patients who have received limited prior chemotherapy. The study aims to determine if this combination therapy can improve clinical outcomes compared to standard treatments. The trial follows a Simon two-stage design to assess the treatment's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with recurrent or metastatic triple-negative breast cancer who have received limited prior chemotherapy.

Not a fit: Patients who have previously received immune checkpoint inhibitors targeting PD-1 or CTLA-4 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced triple-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies, suggesting potential for success in this approach.

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

Where this trial is running

Wuhan, Hubei

• Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Jie Xiong, PhD

Conditions Triple-negative Breast Cancer; Cadonilimab; triple negative breast cancer; chemotherapy