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About this study

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

Condition
Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
Tested
Trastuzumab deruxtecan
Sponsor
AstraZeneca

Who can join

Age
18 to 130 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 130 years
  • Study condition: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
  • 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 4

  • 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

Where

18 sites, 18 recruiting

Research Site

Birmingham, Alabama, United States

Recruiting

Research Site

Boulder, Colorado, United States

Recruiting

Research Site

Bullhead City, Arizona, United States

Recruiting

Research Site

Canton, Ohio, United States

Recruiting

Research Site

Casa Grande, Arizona, United States

Recruiting

Research Site

Coral Springs, Florida, United States

Recruiting

and 12 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.