NCT05632848CompletedPhase 2
Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients
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
Source: ClinicalTrials.gov · Last updated 21 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 6 Nov 2022
- Start date
- 15 Jun 2022
- Primary completion date
- 23 Oct 2024
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05632848
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 47
- From 15 Jun 2022 to the primary completion date, 23 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnant or breast feeding.
- Uncontrolled medical problems.
- Patients were unable or unwilling to comply with program requirements.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.