Pure Global AI
NCT06394661Not yet recruiting

Serplulimab Plus Chemotherapy for Early-stage ER+/HER2- Breast Cancer

Phase II Study Serplulimab Combined With Neoadjuvant Chemotherapy for Early-stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
Henan Cancer HospitalPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Serplulimab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Henan Cancer Hospital
Location
Henan, China
Timeline & enrollment
Phase
Phase 2
Start date
Apr 24, 2024
End date
Dec 30, 2025
Enrollment
109 participants
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
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06394661
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.