Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06860529 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

StatusRecruiting
PhasePhase 2
Started2025-04-15
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Outcome Measures v2
Re-verified, no change to tracked fields
2025-06-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03-01→confirmed 2025-04-15
Study sites0→1
Eligibility criteria+629 characters
3.1 Inclusion Criteria Patients must meet all of the following criteria to be eligible: Age>=: ≥18 years old. Clinical-pathological confirmation: cT2-cT4 -breast cT4dcancer, or cT1c with axillary lymph node metastasis. Histopathologically confirmed clinically and pathologically； Pathologically proven HR+/HER2- invasive breast cancer: defined as: positive for ER and/or PR positive (IHC nuclear staining >≥1%). HerHER2-2 negative (IHC 0, or 1+ without FISH testing, or IHC 2+ with noFISH-negative amplification). Ki67 by FISH)；≥20%. Has clinicallyClinically measurable lesions: Measurable lesions on [...]
Study titlerevised
Serplulimab Combined withWith Chemotherapy for Early-stage HR+/HER2- Breast Cancer
2025-03-02
Original filing
The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer
Trial Details
NCT Number NCT06860529
Lead Sponsor Henan Cancer Hospital
Conditions HR+/HER2- Breast Cancer
Enrollment 357 participants
Start Date 2025-04-15
Primary Completion 2028-03-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19