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Trial Title:
Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients
NCT ID:
NCT05632848
Condition:
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Chidamide plus Zimberelimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide combined with Zimberelimab
Description:
Chidamide: 30mg each time, orally, biw; Zimberelimab, 240mg, IV, every 3 weeks.
Arm group label:
Treatment arm
Other name:
Chidamide (Tucidinostat)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University, Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuan Zhong-yu, MD
Phone:
86-20-87342496
Email:
yuanzhy@sysucc.org.cn
Contact backup:
Last name:
Huang Jia-Jia, MD
Phone:
86-20-87343794
Email:
huangjiaj@sysucc.org.cn
Investigator:
Last name:
Yuan Zhong-yu, MD
Email:
Principal Investigator
Investigator:
Last name:
Huang Jia-Jia, MD
Email:
Sub-Investigator
Start date:
June 15, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05632848
