NCT05592483

An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

A Multi-center, Multi-country Prospective Observational Study of Patients Initiating T-DXd in the First or Second Treatment Line for HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This study will collect real-world clinical and patient reported outcomes (PRO) and diary data from eligible patients with documented Human Epidermal Growth Factor Receptor 2 (HER2+) \[globally\] or HER2-low \[North America only\] in routine clinical practice.

Detailed description

This is a multi-center, observational prospective study that will characterize the demographic and clinical characteristics, treatment patterns, effectiveness, tolerability and its management, and patient experience of Trastuzumab Deruxtecan (T-DXd) in a real-world setting. This study is planned to be conducted in several countries and aims to enroll approximately 750 patients eligible patients with HER2+ unresectable and/or metastatic breast cancer (mBC) who has received a prior anti HER2 based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and has developed disease recurrence during or within 6 months of completing therapy. Approximately 250 eligible patients with HER2-low unresectable and/or mBC who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy will be enrolled into the study in North America only. The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	None (Observational Study)	Not Applicable since observational study

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-05-29
• Completion: 2024-05-29
• First posted: 2022-10-24
• Last updated: 2024-11-07

Locations

125 sites across 9 countries: United States, Austria, Brazil, Canada, Israel, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study