NCT06144944

Neoadjuvant Pyrotinib in HR-positive and HER2-low High-risk Early Breast Cancer

Neoadjuvant Pyrotinib Combined With Chemotherapy Versus Chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) High-risk Early Breast Cancer: an Open-lable, Multi-center, Randomized Phase III Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 17 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-lable, prospective, randomized phase III clinical trial to further validate the efficacy and safety of neoadjuvant pyrotinib combined with chemotherapy in HR-positive/HER2-low (IHC 2+/FISH-negative) high-risk early breast cancer

Conditions

• Breast Cancer Invasive
• Hormone-receptor-positive Breast Cancer
• HER2 Low Breast Carcinoma
• Early-stage Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib, epirubicin or doxorubicin, cyclophosphamide, paclitaxel	Pyrotinib 320 mg orally once daily, and epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.
DRUG	Epirubicin or doxorubicin, cyclophosphamide, paclitaxel	Epirubicin 90 mg/m² or doxorubicin 60 mg/m² plus cyclophosphamide 600 mg/m² intravenously on day 1 for four 3-week cycles followed by paclitaxel 175 mg/m² intravenously on day 1 or four 3-week cycles.

Timeline

• Start date: 2024-01-17
• Primary completion: 2026-06-30
• Completion: 2031-12-31
• First posted: 2023-11-22
• Last updated: 2026-01-30

Locations

1 site across 1 country: China