Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study
AstraZeneca
Summary
This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US
Description
This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options will be eligible for inclusion. Patients with breast, colore…
Eligibility
- Age range
- 18–130 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults aged ≥18 years 2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors); 3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label; 4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent; 5. Patients who ar…
Interventions
- DrugTrastuzumab deruxtecan
Trastuzumab deruxtecan monotherapy
Locations (17)
- Research SiteBirmingham, Alabama
- Research SiteBullhead City, Arizona
- Research SiteCasa Grande, Arizona
- Research SiteSan Diego, California
- Research SiteBoulder, Colorado
- Research SiteCoral Springs, Florida