NCT05367739

Real World Study on the Efficacy and Safety of Anti-HER2 Therapy

A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs.

Detailed description

About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).

Conditions

• Breast Neoplasms
• HER2-positive Breast Cancer

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-05-01
• Completion: 2023-07-01
• First posted: 2022-05-10
• Last updated: 2023-09-07

Locations

1 site across 1 country: China