drugset / Trial / NCT05461690
Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency
Phase 2
Unknown
50 enrolled
Zhejiang Cancer Hospital
Fujian Cancer Hospital · collabHunan Cancer Hospital · collabSun Yat-sen University · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabZhejiang University · collab
NaSingle-groupOpen-labelTreatment
Summary
The incidence of homologous recombination deficiency in metastatic triple negative breast cancer was 52%-59%，PARP plays a key role in sensing DNA damage and converting it into intracellular signals that activate the base excision repair (BER) and single-strand break repair pathways. Treatment with PARP inhibitors could represent a novel opportunity to selectively kill a subset of cancer cells with deficiencies in DNA repair pathways. This is a multicenter, single-arm, phase II study evaluating the efficacy and safety of niraparib in patients with HRD positive metastatic triple negative breast cancer.
Timeline
- Start
- 2022-09-01
- Primary completion
- 2024-12-31
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 200 mg | — |
| Subject | Niraparib | Small molecule | 300 mg | — |