OncRef

Clinical Trial: NCT07162051

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Xijing Hospital
Information Provided By:Xijing Hospital
Last Update Posted:2026-04-13

Study Overview

Brief 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.

Official Title

A Single-arm, Open-label Study of Fluzoparib Combination With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer

Conditions

HR+/HER2- Early Breast Cancer

Intervention / Treatment

  • Drug: Fuzaparib
  • Other: standard chemotherapy

Other Study ID Numbers

  • KY20222031-F-2

Start Date (Actual)

2023-03-03

Primary Completion Date (Actual)

2026-02-15

Study Completion Date (Actual)

2026-03-15

Enrollment (Actual)

28

Study Type

Interventional

Phase

Phase 2