Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation — IMPARP  

Her-2 Negative Breast Cancer Clinical Trial

Official title: A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation

Status Recruiting

Clinical Trial Summary

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.

Clinical Trial Description

This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.

Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.

HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Her-2 Negative Breast Cancer

• NCT number: NCT05761470
• Study type: Interventional
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Ying Lin, MD
• Phone: +8602087755766
• Email: linying3@mail.sysu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2022
• Completion date: December 31, 2028