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

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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