Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, hybrid observational study enrolling about 100 patients in the US who start trastuzumab deruxtecan (T‑DxD) in routine clinical practice per FDA label. Patients must have HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors, have received prior systemic therapy for advanced disease, and not have satisfactory alternative treatments; common tumor types such as breast, colorectal, NSCLC, gastric/GEJ, and hematologic malignancies are excluded. Approximately 30 sites, emphasizing community oncology settings alongside hospital systems and academic centers, will prospectively capture real‑world treatment, tumor response, and timing outcomes. The primary endpoints are real‑world response rate and duration of response, with secondary endpoints including time to treatment discontinuation and time to next treatment.

Why it matters

Who can join: the full rules

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 are willing and able to provide a signed and dated informed consent.

Exclusion Criteria:

1. 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;
2. Prior T-DXd therapy;
3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.
4. Patient is participating in a clinical trial at time of enrolment

Where it's running

• Research Site
  Birmingham, Alabama, United States Recruiting
• Research Site
  Bullhead City, Arizona, United States Recruiting
• Research Site
  Casa Grande, Arizona, United States Recruiting
• Research Site
  San Diego, California, United States Recruiting
• Research Site
  Boulder, Colorado, United States Recruiting
• Research Site
  Coral Springs, Florida, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.