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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.
Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
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.
Time frame: 18 months
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).
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 30 months