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Phase II Study of Niraparib in Metastatic TNBC Patients With Homologous Recombination Deficiency

Triple Negative Breast Cancer Clinical Trial

Official title:
Phase II Study of Niraparib Single Agent in Metastatic Triple Negative Breast Cancer Patients With Homologous Recombination Deficiency

Clinical Trial 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.

Clinical Trial Description

Simon's two-stage optimization method is used to estimate the sample size. The first kind of error α Set to 0.1, type II error β Set to 0.25, P0 to 30%, P1 to 44%. 22 patients were enrolled in the first stage. If the number of effective cases ≤ 6, the trial was terminated. Otherwise, continue to enroll 26 patients in the second stage. If the number of effective cases in the two stages is ≤ 18, there is no need to further study the drug. Assuming an abscission rate of 5%, it is estimated that 50 subjects will be enrolled in the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05461690
Study type Interventional
Source Zhejiang Cancer Hospital
Contact Xiaojia Wang, MD
Phone 13906500190
Email wxiaojia0803@163.com
Status Not yet recruiting
Phase Phase 2
Start date September 1, 2022
Completion date June 30, 2025
View Details
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