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

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632848
• Other study ID #: SYSUCC 019
• Status: Recruiting
• Phase: Phase 2
• Start date: June 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Sun Yat-sen University
• Contact: Zhong-yu Yuan, M.D.
• Phone: 862087342794
• Email: yuanzhy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers related to efficacy	Baseline tumor biopsy from metastatic or recurrent lesions was required, we analyze and compare the difference of tumor immune microenvironment among patients with different responses to this intervention via the single cell sequencing of acquired tumor biopsy.; And peripheral blood samples were collected at baseline, one day before the second cycle treatment and the date of withdrawal from this clinical trial confirmed by researchers. Then peripheral blood mononuclear cell cluster analysis will be performed and compared their changes before and after treatment.	24 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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