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

Primary Purpose

TNBC - Triple-Negative Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fluzoparib+Paclitaxel
Epirubicin+Cyclophosphamide
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer focused on measuring three-negative Breast Cancer with germline BRCA-mutated

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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;

Sites / Locations

  • JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort1: Epirubicin+Cyclophosphamide

Cohort2: Fluzoparib+Paclitaxel

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
AEs and SAEs
adverse events and serious adverse events

Full Information

First Posted
April 18, 2023
Last Updated
April 27, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05834582
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TNBC - Triple-Negative Breast Cancer
Keywords
three-negative Breast Cancer with germline BRCA-mutated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort1: Epirubicin+Cyclophosphamide
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort2: Fluzoparib+Paclitaxel
Arm Type
Experimental
Arm Description
2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles
Intervention Type
Drug
Intervention Name(s)
Fluzoparib+Paclitaxel
Intervention Description
Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy
Intervention Type
Drug
Intervention Name(s)
Epirubicin+Cyclophosphamide
Intervention Description
Epirubicin+Cyclophosphamide
Primary Outcome Measure Information:
Title
tpCR(ypT0/is ypN0)
Description
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 Outcome Measure Information:
Title
Event-free Survival (EFS) as assessed by Investigator
Description
EFS is defined as the time from enrollment to disease progression or death due to any cause
Time Frame
Up to approximately 3 years
Title
AEs and SAEs
Description
adverse events and serious adverse events
Time Frame
From enrollment to the surgery (approximately 6 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoan Liu, Professor
Phone
025-68308162
Email
liuxiaoan@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoan Liu, Professor
Organizational Affiliation
Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoan Liu, Professor
Phone
025-68308162
Email
liuxiaoan@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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