NCT05834764

Pyrotinib in Women With High-risk in Early Stage Breast Cancer

Evaluating the Efficacy and Safety of Pyrotinib After Adjuvant Anti-HRE2 Therapy in Women With High-risk in Early or Locally Advanced Stage Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

ExteNET study explored neratinib prolong anti-HER2 therapy after trastuzumab therapy found that it can improve disease-free survival in patients with lymph nodes positive; In addition, the subgroup of patients with residual tumors after neoadjuvant therapy was found to improve the survival. However, no conclusive conclusions were reached. However, since the study was carried out early so only trastuzumab treatment was used, it is urgent to carry out research that is more in line with current clinical practice and bring more benefits to patients. To explore whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER2-positive breast cancer after treatment with trastuzumab and pertuzumab or T-DM1.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Pyrotinib	Pyrotinib after anti-HER2 therapy（Trastuzumab combined with Pertuzumab or T-DM1）

Timeline

• Start date: 2023-04-08
• Primary completion: 2026-06-01
• Completion: 2028-12-31
• First posted: 2023-04-28
• Last updated: 2023-04-28

Locations

1 site across 1 country: China