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

NCT ID: NCT05632848

Last Updated: 2025-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2025-02-21

Brief 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.

Detailed 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.

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Chidamide and Zimberelimab

Group Type: EXPERIMENTAL

Chidamide combined with Zimberelimab

Intervention Type: DRUG

Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.

Interventions

Chidamide combined with Zimberelimab

Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

Chidamide (Tucidinostat)

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 Zimberelimab
• Patients were unable or unwilling to comply with program requirements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong-yu Yuan, M.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC 019

Identifier Type: -

Identifier Source: org_study_id