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Trial Title:
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer
NCT ID:
NCT06367088
Condition:
Triple-negative Breast Cancer
Cadonilimab
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
triple negative breast cancer
Cadonilimab
chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab
Description:
Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination
with chemotherapy. The chemotherapy regimen is chosen by the physician.
Arm group label:
Experimental Arm
Other name:
physician's choice of chemotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Xiong
Phone:
+8615927611872
Email:
xxiongjie2000@163.com
Start date:
May 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06367088
