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

Sponsor
Henan Cancer Hospital
Study ID
NCT06781281
Status
Recruiting
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Conditions

  • Breast Cancer Invasive

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Serplulimab
  • NabPE — DRUG
    Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2

Study Details

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.

Key Dates

Start date
Dec 4, 2024
Status verified
Jun 2025
Primary completion
Nov 28, 2026
Completion
Nov 28, 2030

Study Design

Enrollment
709 participants (estimated)

Arms

  • Arm: NabPE+Serplulimab group
    Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3, every 3 weeks for 6 cycles.
  • Arm: NabPE
    Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1, every 3 weeks for 6 cycles.

Primary Outcome Measure

pathological complete response [ Time Frame: 24 weeks ]

Central Contacts

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