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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Research Site
RECRUITING
Birmingham
Arizona
Research Site
RECRUITING
Casa Grande
Florida
Research Site
RECRUITING
Coral Springs
Research Site
RECRUITING
Fort Myers
Illinois
Research Site
RECRUITING
O'fallon
North Carolina
Research Site
RECRUITING
Wilson
Ohio
Research Site
RECRUITING
Canton
Research Site
RECRUITING
Maumee
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-09-18
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 100
Treatments
Trastuzumab deruxtecan
Patients with locally advanced, unresectable, or metastatic HER-2 positive (IHC3+) solid tumours for whom a clinician decision has been made for treatment with T-DXd as part of routine clinical practice and in line with the FDA label
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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