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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGObjective Response Rate
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Time frame: Up to 2 years
AE
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: From the time of informed consent signed through 90 days after the last dose of drug
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