Serplulimab Plus Chemotherapy for Early-stage ER+/HER2- Breast Cancer - Trial NCT06394661
Access comprehensive clinical trial information for NCT06394661 through Pure Global AI's free database. This Phase 2 trial is sponsored by Henan Cancer Hospital and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 109 participants.
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Study Focus
Sponsor & Location
Henan Cancer Hospital
Timeline & Enrollment
Phase 2
Apr 24, 2024
Dec 30, 2025
Primary Outcome
pathological complete response
Summary
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2-
 breast cancer. It will also learn about the safety of serplulimab. 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 3 cycles.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06394661
Non-Device Trial