NCT05761470 Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
| NCT ID | NCT05761470 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ying Lin |
| Condition | Her-2 Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2022-05-06 |
| Primary Completion | 2024-06-30 |
Trial Parameters
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Brief 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 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 immunosuppres
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