Overview
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.
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.
Eligibility
Inclusion Criteria:
- Patients ≥18 years of age at time of consent.
- Histological or cytological confirmed diagnosis of unresectable and/or mBC.
- Documented HER2 status via a validated method.
- Adult patients with unresectable or metastatic HER2+ breast cancer who have received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing therapy.
Or
Adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast
cancer who have received a prior chemotherapy in the metastatic setting or developed
disease recurrence during or within 6 months of completing adjuvant chemotherapy.
- Decision to newly initiate monotherapy T-DXd per standard of care.
- Capable of providing informed consent and completing questionnaires.
Exclusion Criteria:
- Pregnancy or breastfeeding.
- History of other primary malignancies in 2 years prior to unresectable and/or mBC
diagnosis.
- Patients who at time of data collection for this study are participating in or have
participated in an interventional study that remains blinded.