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

NCT05834582 | Recruiting Phase 2

• 1 other identifier: MA-BC-II-050
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

TNBC - Triple-Negative Breast Cancer

Keywords

three-negative Breast Cancer with germline BRCA-mutated

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months from the patients enrolled

Secondary Outcomes (2)

• Event-free Survival (EFS) as assessed by Investigator

  Up to approximately 3 years

• AEs and SAEs

  From enrollment to the surgery (approximately 6 months)

Study Arms (2)

Cohort1: Epirubicin+Cyclophosphamide

EXPERIMENTAL

2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is CR or PR: Epirubicin+Cyclophosphamide for 2 cycles Fluzoparib+Paclitaxel for 2 cycles

Drug: Fluzoparib+Paclitaxel; Drug: Epirubicin+Cyclophosphamide

Cohort2: Fluzoparib+Paclitaxel

EXPERIMENTAL

2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles

Drug: Fluzoparib+Paclitaxel; Drug: Epirubicin+Cyclophosphamide

Interventions

Fluzoparib+Paclitaxel DRUG

Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy

Cohort1: Epirubicin+Cyclophosphamide; Cohort2: Fluzoparib+Paclitaxel

Epirubicin+Cyclophosphamide DRUG

Epirubicin+Cyclophosphamide

Cohort1: Epirubicin+Cyclophosphamide; Cohort2: Fluzoparib+Paclitaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
• 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%
• Tumor stage: II-III: Primary tumor size: ≥ 2cm
• ECOG score 0 \~ 1;
• Centrally confirmed BRCA1 or BRCA2 germline mutation;
• Eligible level of organ function

You may not qualify if:

• Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer;
• 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;
• Previously received PARPi therapy;
• History of another primary malignancy;
• Confirmed history of heart failure or systolic dysfunction (LVEF \< 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia;
• Female patients who are pregnant or lactating;
• History of allergy to drugs in this study；

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

EC regimen

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaoan Liu, Professor

  Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoan Liu, Professor

CONTACT

025-68308162; liuxiaoan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: April 8, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: April 28, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)