RecruitingPhase 2NCT07162051

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

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


Sponsor

Xijing Hospital

Enrollment

28 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining fluzoparib (a PARP inhibitor — a type of DNA-repair blocking drug) with standard chemotherapy before surgery can shrink tumors more effectively in women with a specific type of breast cancer that has certain DNA repair defects. **You may be eligible if...** - You are a woman aged 18 to 70 with newly diagnosed breast cancer - Your cancer is hormone receptor-positive and HER2-negative (HR+/HER2−) - Your cancer has a DNA repair defect called HRD (homologous recombination deficiency) or a BRCA1/2 gene mutation - Your tumor is large enough or your lymph nodes are involved to qualify for pre-surgery (neoadjuvant) chemotherapy - You have adequate organ function **You may NOT be eligible if...** - You have already received chemotherapy or targeted therapy for this breast cancer - You have metastatic (stage IV) breast cancer - You have had another cancer in the past 5 years - You have significant liver, kidney, or blood count problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFuzaparib

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.

OTHERstandard chemotherapy

standard chemotherapy


Locations(1)

Xijing hospital

Xi'an, Shaanxi, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07162051


Related Trials