RecruitingPhase 2NCT06860529

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer


Sponsor

Henan Cancer Hospital

Enrollment

357 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding serplulimab (an immunotherapy drug that helps the immune system attack cancer cells) to standard chemotherapy before surgery improves outcomes for patients with high-risk hormone receptor-positive, HER2-negative early breast cancer. **You may be eligible if...** - You are 18 or older with histologically confirmed HR+/HER2-negative invasive breast cancer - Your tumor is at least cT2 size, or cT1c with lymph node involvement - Your tumor has a Ki67 value of 20% or higher (indicating fast-growing cancer) - Your blood counts and organ function meet required thresholds - There is a measurable tumor on imaging (ultrasound, mammography, or MRI) within 1 month before treatment **You may NOT be eligible if...** - You have metastatic (stage 4) breast cancer - You have active autoimmune disease or have required systemic steroids recently - You have received prior chemotherapy or radiation for this cancer - You have serious cardiovascular, liver, kidney, or lung problems - You are pregnant or breastfeeding 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.

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Interventions

DRUGSerplulimab

Serplulimab is administered intravenously

DRUGEpirubicin

Epirubicin ivgtt

DRUGAlbumin Paclitaxel

Albumin Paclitaxel ivgtt


Locations(1)

Henan cancer hospital

Zhengzhou, Henan, China

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NCT06860529


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