Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Recruiting · NCT05761470 · Interventional (participants receive a specific treatment) · Lead sponsor: Ying Lin
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- First Affiliated Hospital, Sun Yat-Sen University - Guangzhou, Guangdong, China