NCT06367088RecruitingPhase 2
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 10 Apr 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06367088
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 27
- From 1 May 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)；
Other illness
- Patients with an active autoimmune disease that requires systemic treatment in the past two years；
- A known history of primary immunodeficiency；
Lab values
- Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study
Other
- Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases；
- Pregnant or lactating women；
Who the study is looking for
- 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;
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.