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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with early-stage triple-negative breast cancer (TNBC) that is linked to a BRCA gene mutation. The researchers want to see if a medication called fluzoparib, when combined with standard chemotherapy, can help improve treatment outcomes for these patients. The trial will involve around 60 women aged between 18 and 70 who have not received any prior treatment for their breast cancer. To be eligible, participants need to have a specific type of breast cancer that meets certain criteria, including having tumors that are at least 2 cm in size and are confirmed to have a BRCA1 or BRCA2 gene mutation.

Participants in this trial can expect to receive fluzoparib along with chemotherapy after undergoing two cycles of initial treatment with epirubicin and cyclophosphamide. The study is currently recruiting patients, and it is important to note that women with recent heart issues, other types of breast cancer, or those who are pregnant or breastfeeding cannot participate. This trial aims to explore whether fluzoparib can provide additional benefits for women with this challenging type of breast cancer.

Gender

FEMALE

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；