Clinical trial NCT05834582: Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
Official title: Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: TNBC - Triple-Negative Breast Cancer
Keywords: three-negative Breast Cancer with germline BRCA-mutated
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2023-04-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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；

Primary outcomes:
measure: tpCR（ypT0/is ypN0）
timeFrame: 6 months from the patients enrolled
Secondary outcomes:
measure: Event-free Survival (EFS) as assessed by Investigator
timeFrame: Up to approximately 3 years
measure: AEs and SAEs
timeFrame: From enrollment to the surgery (approximately 6 months)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
name: Xiaoan Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References: