NCT06231693

Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\<10%) metastatic HER2-Low breast cancer.

Detailed description

Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	Patients with RE\<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting

Timeline

• Start date: 2023-12-04
• Primary completion: 2024-03-26
• Completion: 2024-03-26
• First posted: 2024-01-30
• Last updated: 2025-05-08

Locations

2 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study