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

Nanjing Medical University

Status and phase: Enrolling; Phase 2

Conditions: TNBC - Triple-Negative Breast Cancer

Treatments: Drug: Epirubicin+Cyclophosphamide; Drug: Fluzoparib+Paclitaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05834582

MA-BC-II-050

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort1: Epirubicin+Cyclophosphamide

Experimental group

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

Treatment:

Drug: Fluzoparib+Paclitaxel

Drug: Epirubicin+Cyclophosphamide

Cohort2: Fluzoparib+Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Fluzoparib+Paclitaxel

Drug: Epirubicin+Cyclophosphamide