drugset / Trial / NCT07162051

A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer

NCT07162051

Phase 2 Completed 28 enrolled Xijing Hospital
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide for HRD-positive, HR+/HER2- early breast cancer. The main question it aims to answer is: Does the proportion of patients with residual tumor burden (RCB) 0/I increase when Fluzoparib combined with docetaxel is sequentially followed by paclitaxel combined with cyclophosphamide for patients with HRD-positive, HR+/HER2- early breast cancer? What medical problems will participants encounter when using Fluzoparib combined with docetaxel in sequential paclitaxel combined with cyclophosphamide? Participants will: After confirming their enrollment, they need to receive the trial drug treatment within 72 hours, with each 3-week period as a treatment cycle, for a total of 8 cycles. The first to fourth cycles will receive Fluzoparib combined with docetaxel treatment, and the fifth to eighth cycles will receive paclitaxel and cyclophosphamide treatment. The treatment will continue until the end of the treatment course or disease progression, occurrence of intolerable toxicity, or the subject withdrawing the informed consent form.

Timeline

Start
2023-03-03
Primary completion
2026-02-15
Completion
2026-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Fuzaparib Unknown 100 mg
Subject Fuzaparib Unknown 150 mg
Background Cyclophosphamide Other / unclassified
Background Docetaxel Small molecule
Background Paclitaxel Small molecule
Background Platinum Small molecule