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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Histologically documented Her-2 negative
• TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
• No distant metastatic disease
• Eastern Cooperative Oncology Group Performance Status: 0\
⁃ 1
• HRR gene mutation: 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.
Locations
Other Locations
China
First Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Ying Lin, MD
linying3@mail.sysu.edu.cn
+8602087755766
Backup
Xiaying Kuang, MD
kuangxy5@mail.sysu.edu.cn
+8602087755766
Time Frame
Start Date: 2022-05-06
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 66
Treatments
Experimental: Camrelizumab, Fluzoparib and Nab-paclitaxel
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
Related Therapeutic Areas
Sponsors
Leads: Ying Lin