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

TNBC - Triple-Negative Breast Cancer Clinical Trial

Official title:

Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834582
• Other study ID #: MA-BC-II-050
• Status: Recruiting
• Phase: Phase 2
• Start date: April 8, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Xiaoan Liu, Professor
• Phone: 025-68308162
• Email: liuxiaoan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Neoplasms
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Fluzoparib+Paclitaxel
Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy
• Epirubicin+Cyclophosphamide
Epirubicin+Cyclophosphamide

Locations

Country	Name	City	State
China	JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Up to approximately 3 years
Secondary	AEs and SAEs	adverse events and serious adverse events	From enrollment to the surgery (approximately 6 months)