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

• Status: Recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ying Lin
• Treatments: Paclitaxel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who are pregnant or lactating at the time of randomization or refuse to contraception.

• Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ

• Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.

• Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.

• Patients who have used immunosuppressive drug or corticosteroids within 14 days.

• Patients who have other diseases which researchers.

• Patients who allergy to any of the drugs in this trail.