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

NCT05632848 | Completed Phase 2 DMC

• 1 other identifier: SYSUCC 019
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

Chidamide plus Zimberelimab

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The proportion of patients with measurable tumor size reduction of a predefined amount (complete response \[CR\], partial response \[PR\]) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  18 months

Secondary Outcomes (4)

• Clinical benefit rate (CBR)

  18 months

• Progression Free Survival (PFS)

  24 months

• Overall Survival (OS)

  30 months

• Occurrence and severity of AEs

  30 months

Other Outcomes (1)

• Biomarkers related to efficacy

  24 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Chidamide and Zimberelimab

Drug: Chidamide combined with Zimberelimab

Interventions

Chidamide combined with Zimberelimab DRUG

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

Also known as: Chidamide (Tucidinostat)

Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University, Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

zimberelimab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhong-yu Yuan, M.D.

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: December 1, 2022
• Study Start: June 15, 2022
• Primary Completion: October 23, 2024
• Study Completion: February 21, 2025
• Last Updated: July 21, 2025

Record last verified: 2025-07

Locations

CN (1)