Recruiting
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.
ClinicalTrials.gov IDNCT05761470
PhasePHASE2
Enrollment66
SponsorYing Lin
Age18 Years
SexALL
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
- Drug: 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.
- Drug: Fluzoparib — Fluzoparib
- Drug: Nab-paclitaxel — Nab-paclitaxel
Primary outcomes
- Pathologic Complete Response (pCR) (Up to 32 weeks)
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
- First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong 510080 China
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.