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Recruiting
NCT05632848
Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients
Conditions: Triple Negative Breast Cancer
Sex: Female
Ages: 18 Years – 70 Years
Phase: PHASE2
Enrollment: 47
Sponsor: Sun Yat-sen University
Location: China
Summary
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.
Eligibility Criteria
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 ZimberelimabPatients were unable or unwilling to comply with program requirements.
Source: ClinicalTrials.gov (NCT05632848). StuddyBuddy aggregates publicly available trial information.