Actively Recruiting
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-04-28
60
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
CONDITIONS
Official Title
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years with treatment-naïve breast cancer
- Histopathological confirmation of early or locally advanced triple-negative invasive breast cancer according to ASCO/CAP guidelines
- HER2 negative by IHC and ISH testing; ER and PR negative (IHC nuclear staining ≤ 1%)
- Tumor stage II to III with primary tumor size ≥ 2 cm
- ECOG performance status 0 to 1
- Centrally confirmed germline BRCA1 or BRCA2 mutation
- Adequate organ function
You will not qualify if you...
- Presence of metastatic, bilateral, or inflammatory breast cancer
- Participation in other drug trials or receipt of anti-tumor therapy within 4 weeks prior to enrollment
- Prior treatment with PARP inhibitors
- History of another primary cancer
- History of heart failure, systolic dysfunction (LVEF < 50%), or uncontrolled cardiac arrhythmias
- Pregnant or lactating women
- History of allergy to drugs used in this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
X
Xiaoan Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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