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

NCT ID: NCT05834582

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-08

Study Completion Date

2026-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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TNBC - Triple-Negative Breast Cancer

Keywords

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three-negative Breast Cancer with germline BRCA-mutated

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort1: Epirubicin+Cyclophosphamide

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

Group Type EXPERIMENTAL

Fluzoparib+Paclitaxel

Intervention Type DRUG

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

Epirubicin+Cyclophosphamide

Intervention Type DRUG

Epirubicin+Cyclophosphamide

Cohort2: Fluzoparib+Paclitaxel

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

Group Type EXPERIMENTAL

Fluzoparib+Paclitaxel

Intervention Type DRUG

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

Epirubicin+Cyclophosphamide

Intervention Type DRUG

Epirubicin+Cyclophosphamide

Interventions

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Fluzoparib+Paclitaxel

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

Intervention Type DRUG

Epirubicin+Cyclophosphamide

Epirubicin+Cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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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；
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Liu Xiaoan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoan Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoan Liu, Professor

Role: CONTACT

Phone: 025-68308162

Email: [email protected]

Facility Contacts

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Xiaoan Liu, Professor

Role: primary

Other Identifiers

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MA-BC-II-050

Identifier Type: -

Identifier Source: org_study_id