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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients: A Single-armed, Phase II Trial

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: Chidamide combined with Zimberelimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Chidamide and Zimberelimab | Drug: Chidamide combined with Zimberelimab<br>* Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.<br>* Other names: Chidamide (Tucidinostat);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit rate (CBR) | 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). | 18 months | 
| Progression Free Survival (PFS) | 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. | 24 months | 
| Overall Survival (OS) | The interval time from the date of initiation treatment for metastatic breast cancer to the date of death from any cause. | 30 months | 
| Occurrence and severity of AEs | 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. | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chidamide plus Zimberelimab