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NCT05761470
Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Conditions: Her-2 Negative Breast Cancer, HRR Gene Mutation
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE2
Enrollment: 66
Sponsor: Ying Lin
Location: China
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 negativeTNM stage: T1c, N1-N2;T2-4, N0-N2;any T, N3No distant metastatic diseaseEastern Cooperative Oncology Group Performance Status: 0~1HRR 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 situPatients 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.
Source: ClinicalTrials.gov (NCT05761470). StuddyBuddy aggregates publicly available trial information.