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

Phase 2

Recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: Chidamide combined with Zimberelimab

• Registration Number: NCT05632848
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2022-06-15
• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Chidamide combined with Zimberelimab	Chidamide and Zimberelimab

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	24 months	The interval time from the date of initiation treatment for metastatic breast cancer to the date of the first documented disease progression or death due to any cause.
Clinical benefit rate (CBR)	18 months	The proportion of patients with measurable tumor size stable lasting ≥24 weeks (stable disease \[SD\]) or its size reduction of a predefined amount (complete response \[CR\], partial response \[PR\]) following the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response (CR) and Partial Response (PR) are defined in Primary Outcome Measure. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease), taking as reference the smallest sum diameters while on study. Progressive Disease: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). (Note: the appearance of one or more new lesions is also considered progression).
Occurrence and severity of AEs	30 months	Occurrence and severity of AEs by NCI-CTCAE v5. Changes in laboratory parameters (hematology and serum chemistry), vital signs and ECG parameters. Grade 3 or 4 abnormalities in serum chemistry laboratory parameters.
Overall Survival (OS)	30 months	The interval time from the date of initiation treatment for metastatic breast cancer to the date of death from any cause.

Trial Locations

Locations (1)

Sun Yat-sen University, Cancer Center; 🇨🇳 Guangzhou, Guangdong, China