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NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
Sponsor: Henan Cancer Hospital
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
709
Start Date
2024-12-04
Completion Date
2030-11-28
Last Updated
2025-06-23
Healthy Volunteers
No
Conditions
Interventions
Serplulimab
Serplulimab
NabPE
Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2
Locations (1)
Henan cancer hospital
Zhengzhou, China