Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer

Phase 2RecruitingNCT05834582

The First Affiliated Hospital with Nanjing Medical University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

TNBC - Triple-Negative Breast Cancer

Interventions

Fluzoparib+Paclitaxel

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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；

Outcomes

Primary Outcomes

tpCR（ypT0/is ypN0）

pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0).

Time frame: 6 months from the patients enrolled

Secondary Outcomes

Event-free Survival (EFS) as assessed by Investigator

EFS is defined as the time from enrollment to disease progression or death due to any cause

Time frame: Up to approximately 3 years

AEs and SAEs

adverse events and serious adverse events

Time frame: From enrollment to the surgery (approximately 6 months)