Using Fluzoparib with Chemotherapy for Triple-Negative Breast Cancer Patients with BRCA Mutations

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

This study tests if adding a new drug called fluzoparib to standard chemotherapy can help women with triple-negative breast cancer and BRCA mutations have better treatment results.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: immunotherapy, chemotherapy, cyclophosphamide
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05834582 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of fluzoparib, a PARP inhibitor, combined with chemotherapy in women with germline BRCA-mutated triple-negative breast cancer (TNBC). The study is an open-label, multicenter trial that plans to enroll 60 patients who will receive fluzoparib alongside standard chemotherapy after initial treatment with epirubicin and cyclophosphamide. The goal is to assess the tumor response and determine if this combination improves outcomes for patients with this aggressive cancer type.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 70 with treatment-naïve, early-stage or locally advanced triple-negative breast cancer and a confirmed BRCA1 or BRCA2 mutation.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who have previously received PARP inhibitor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could provide a new effective option for patients with BRCA-mutated triple-negative breast cancer.

How similar studies have performed: While many PARP inhibitors have not shown improvement in neoadjuvant settings for TNBC, this approach is exploring a potentially novel combination that has not been extensively tested.

Eligibility criteria

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；

Where this trial is running

Nanjing, Jiangsu

• JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Xiaoan Liu, Professor — Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
• Study coordinator: Xiaoan Liu, Professor

Conditions TNBC - Triple-Negative Breast Cancer; three-negative Breast Cancer with germline BRCA-mutated