NCT06367088 Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
| NCT ID | NCT06367088 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 27 participants in total. It began in 2024-05-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Yanxia Zhao, PhD
STUDY CHAIR
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06367088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Triple-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06367088 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06367088 currently recruiting?
Yes, NCT06367088 is actively recruiting participants. Contact the research team at xxiongjie2000@163.com for enrollment information.
Where is the NCT06367088 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06367088 clinical trial?
NCT06367088 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Yanxia Zhao, PhD at Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 27 participants.
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