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RecruitingPhase 2NCT05761470

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

A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation

Sponsor

Ying Lin

Enrollment

66 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Her-2 Negative Breast CancerHRR Gene Mutation

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.

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Interventions

DRUGCamrelizumab

Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle. Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.

DRUGFluzoparib

Fluzoparib

DRUGNab-paclitaxel

Nab-paclitaxel

Locations(1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT05761470