DESTINY-PANTUMOUR04
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
About This Trial
- This study looks at how well a targeted drug called T-DXd works in everyday medical care for adults with advanced cancers that have spread or cannot be removed with surgery.
- It is designed for patients whose tumors test positive for high levels of a specific protein known as HER2.
- To be eligible, you must have already received standard treatments for your advanced disease and have no other satisfactory treatment options left.
- Before considering this study, your doctor will need to confirm your tumor has high HER2 levels, and you must not have received this specific medication in the past.
More Information
- 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
Who Can Enroll
- Age Range: 18 - 130 years
- Gender: All
- Who This Trial is For: This study looks at how well a targeted drug called T-DXd works in everyday medical care for adults with advanced cancers that have spread or cannot be removed with surgery.
Study Details
- Start Date: September 18, 2025
- Lead Sponsor: AstraZeneca
Full Eligibility Criteria
Inclusion Criteria
- Adults aged ≥18 years
- 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);
- A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;
- HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;
- Patients who are willing and able to provide a signed and dated informed consent.
Exclusion Criteria
- Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;
- Prior T-DXd therapy;
- Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
- Patient is participating in a clinical trial at time of enrolment
Treatments
- Drug: Trastuzumab deruxtecan