OncoMatch/Clinical Trials/NCT06367088
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
Is NCT06367088 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Cadonilimab for triple-negative breast cancer.
Treatment: Cadonilimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 ER<1% (<1%)
TNBC defined by immunohistochemistry as ER<1%
Required: PR (PGR) PR<1% (<1%)
TNBC defined by immunohistochemistry as PR<1%
Required: HER2 (ERBB2) 0~1+ or 2+ while HER2 Fish test shows no amplification (0~1+ or 2+ (IHC) and FISH negative)
Her2=0~1+, or 2+ while HER2 Fish test shows no amplification
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: checkpoint inhibitor
They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)
Lab requirements
Kidney function
acceptable renal function
Liver function
acceptable liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06367088 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 ER<1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR PR<1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 0~1+ or 2+ while HER2 Fish test shows no amplification is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify