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 (May 2026). This Phase 2 trial studies Cadonilimab for triple-negative breast cancer.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT06367088Data as of May 2026

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.

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Extracted eligibility criteria

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)

Prior therapy

Max 1 prior line

Min 0 prior lines

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.

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