Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients

Sun Yat-sen University

Status and phase

Completed

Phase 2

Conditions

Triple Negative Breast Cancer

Treatments

Drug: Chidamide combined with Zimberelimab

Study type

Interventional

Funder types

Other

Identifiers

NCT05632848

SYSUCC 019

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.