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RECRUITING
NCT06781281

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

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Serplulimab

Serplulimab

DRUG

NabPE

Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2

Locations (1)

Henan cancer hospital

Zhengzhou, China