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Clinical Trials in China / NCT05761470
Recruiting Phase 2

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

NCT05761470 · tracked via the Priya Life Science China tracker
Sponsor
Ying Lin
Phase
Phase 2
Started
2022-05-06
Last updated
2023-03-09

Condition(s) studied

Her-2 Negative Breast CancerHRR Gene Mutation

Investigational drug(s) / intervention(s)

CamrelizumabFluzoparibNab-paclitaxel

Camrelizumab: 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.

Fluzoparib: Fluzoparib

Nab-paclitaxel: Nab-paclitaxel

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05761470 on ClinicalTrials.gov ↗ ← All trials in China