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

NCT06781281 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 709

Last updated 2025-06-23

No results posted yet for this study

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.

Conditions

  • Breast Cancer Invasive

Interventions

DRUG

Serplulimab

Serplulimab

DRUG

NabPE

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

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2026-11-28
Completion
2030-11-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06781281 on ClinicalTrials.gov