Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYing Lin
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Camrelizumab
- Fluzoparib
- Nab-paclitaxel
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Ying Lin
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Sponsor institution
Source ClinicalTrials.gov