TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
three-negative Breast Cancer with germline BRCA-mutated
Brief summary
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.
Interventions
DRUGFluzoparib+Paclitaxel
Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy
Epirubicin+Cyclophosphamide
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer 2. Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions: HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1% 3. Tumor stage: II-III: Primary tumor size: ≥ 2cm 4. ECOG score 0 \ 1; 5. Centrally confirmed BRCA1 or BRCA2 germline mutation; 6. Eligible level of organ function
Exclusion criteria
1. Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer; 2. Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization; 3. Previously received PARPi therapy; 4. History of another primary malignancy; 5. Confirmed history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; 6. Female patients who are pregnant or lactating; 7. History of allergy to drugs in this study；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tpCR（ypT0/is ypN0） | 6 months from the patients enrolled | pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free Survival (EFS) as assessed by Investigator | Up to approximately 3 years | EFS is defined as the time from enrollment to disease progression or death due to any cause |
| AEs and SAEs | From enrollment to the surgery (approximately 6 months) | adverse events and serious adverse events |
Countries
China
Contacts
Primary ContactXiaoan Liu, Professor
Outcome results
None listed