Combining Chidamide and Zimberelimab for treating metastatic triple-negative breast cancer
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
This study is testing a new treatment that combines Chidamide and Zimberelimab to see if it helps people with metastatic triple-negative breast cancer who have already tried other therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | Zimberelimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05632848 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to assess the efficacy and safety of a new treatment regimen that combines Chidamide with Zimberelimab in patients with metastatic triple-negative breast cancer who have already undergone second-line therapy. The study will recruit 47 participants and will be conducted at a single center. Participants will be evaluated based on their measurable lesions and overall health status, ensuring they meet specific inclusion criteria while excluding those with certain medical conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically confirmed metastatic triple-negative breast cancer who have failed previous anti-tumor treatments.
Not a fit: Patients who are pregnant, have uncontrolled medical problems, or have severe hypersensitivity to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic triple-negative breast cancer who have limited treatment alternatives.
How similar studies have performed: While the combination of Chidamide and Zimberelimab is a novel approach, similar studies exploring combination therapies in triple-negative breast cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University, Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Zhong-yu Yuan, M.D.
- Email: yuanzhy@sysucc.org.cn
- Phone: 862087342794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.