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.
An Observational Study of Patients Receiving T-DXd for Treatment of HER2+, and HER2-low Unresectable and/or Metastatic Breast Cancer
DESTINY BREAST - RESPOND: 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 (D9673R00025)
Breast cancer
All genders
16+
Recruiting now
Overview
Principal Investigator: Rachel Buchsbaum, MD
Contact Us
Latoya Lashley
Study details
Inclusion Criteria
- 1. Histological or cytological confirmed diagnosis of unresectable and/or mBC.
- 2. Documented HER2 status via a validated method.
- 3. 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.
Exclusion Criteria
- 1. Pregnancy or breastfeeding.
- 2. History of other primary malignancies in 2 years prior to unresectable and/or mBC diagnosis.
- 3. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
Study Requirements
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. The planned duration of patient recruitment is approximately 18 months for HER2+ and approximately 12 months for HER2 low.