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Trial Title:
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
NCT ID:
NCT05834582
Condition:
TNBC - Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Epirubicin
Fluzoparib
Conditions: Keywords:
three-negative Breast Cancer with germline BRCA-mutated
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fluzoparib+Paclitaxel
Description:
Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced
chemotherapy
Arm group label:
Cohort1: Epirubicin+Cyclophosphamide
Arm group label:
Cohort2: Fluzoparib+Paclitaxel
Intervention type:
Drug
Intervention name:
Epirubicin+Cyclophosphamide
Description:
Epirubicin+Cyclophosphamide
Arm group label:
Cohort1: Epirubicin+Cyclophosphamide
Arm group label:
Cohort2: Fluzoparib+Paclitaxel
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.
Criteria for eligibility:
Criteria:
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；
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoan Liu, Professor
Phone:
025-68308162
Email:
liuxiaoan@126.com
Start date:
April 8, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05834582
