RecruitingNCT06781281

NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast cancer-an Observational Real-world Study.

Sponsor

Henan Cancer Hospital

Enrollment

709 participants

Start Date

Dec 4, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Invasive

Summary

The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (serplulimab) to chemotherapy (nab-paclitaxel and epirubicin) before surgery works better than chemotherapy alone for women with early-stage hormone receptor-positive, HER2-negative breast cancer — a common type of breast cancer that tends to grow more slowly. **You may be eligible if...** - You are 18 or older and female - You have hormone receptor-positive, HER2-negative breast cancer - Your cancer is stage T1c with lymph node involvement, or stage T2–T4d - You have not received prior treatment for this breast cancer - Your heart function is normal (ejection fraction ≥55%) **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have already received chemotherapy or immunotherapy for this cancer - You have a serious heart condition or another active cancer - You are pregnant 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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