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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Jie Xiong, PhD
• Email: xxiongjie2000@163.com
• Phone: +86-15927611872

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• FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.