Overview
The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.
Description
This is a phase II, single center, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. This study plans to recruit 47 subjects.
Eligibility
Inclusion Criteria:
- Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis.
- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- Fail first-line or above anti-tumor treatment.
- Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
- Compliance with the study protocol.
- Have provided written and signed informed consent.
- Minimum life expectancy 16 weeks.
Exclusion Criteria:
- Pregnant or breast feeding.
- Uncontrolled medical problems.
- Evidence of active acute or chronic infection.
- Hepatic, renal, cardiac, or bone marrow dysfunction.
- Concurrent malignancy or history of other malignancy within the last five years.
- Known severe hypersensitivity to Chidamide or Zimberelimab
- Patients were unable or unwilling to comply with program requirements.