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

NCT07162051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • HR+/HER2- Early Breast Cancer

Interventions

DRUG

Fuzaparib

Folfoxapril: Take 2 times a day (once in the morning and once in the evening, 150mg in the morning and 100mg in the evening; vice versa is also acceptable). Each 3-week period constitutes one cycle. For the first to fourth cycles, a total of 4 cycles are required.

OTHER

standard chemotherapy

standard chemotherapy

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162051 on ClinicalTrials.gov