Clinical trial · Interventional
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
NCT05632848CI-TRIAL-00092406completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide combined with Zimberelimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Chidamide and Zimberelimab
- interventionNames
- Drug: Chidamide combined with Zimberelimab
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 18 months
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.