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

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.

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ClinicalTrials.gov IDNCT05761470
PhasePHASE2
Enrollment66
SponsorYing Lin
Age18 Years and older
SexALL
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Conditions studied

Her-2 Negative Breast Cancer, HRR Gene Mutation

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.