What this study is
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
What's being tested
- Trastuzumab deruxtecan
Intervention · DRUG
Trastuzumab deruxtecan monotherapy
Study details
- Official title
- 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
- Sponsor
- AstraZeneca
- Conditions
- 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
- Enrolling
- 100 people
- Starts
- 2025-09-18
- Est. completion
- 2028-03-30
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 130 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (18)
18 openResearch Site
Birmingham, Alabama, United States
RecruitingResearch Site
Bullhead City, Arizona, United States
RecruitingResearch Site
Casa Grande, Arizona, United States
RecruitingResearch Site
San Diego, California, United States
RecruitingResearch Site
Boulder, Colorado, United States
RecruitingResearch Site
Coral Springs, Florida, United States
RecruitingResearch Site
St. Petersburg, Florida, United States
RecruitingResearch Site
West Palm Beach, Florida, United States
RecruitingResearch Site
Decatur, Illinois, United States
RecruitingResearch Site
Topeka, Kansas, United States
RecruitingResearch Site
Farmington, New Mexico, United States
RecruitingResearch Site
Durham, North Carolina, United States
RecruitingResearch Site
Wilson, North Carolina, United States
RecruitingResearch Site
Canton, Ohio, United States
RecruitingResearch Site
Maumee, Ohio, United States
RecruitingResearch Site
Philadelphia, Pennsylvania, United States
RecruitingResearch Site
Nashville, Tennessee, United States
RecruitingResearch Site
Dallas, Texas, United States
Recruiting
Study team
Sponsor
AstraZeneca
Study ID D781WR00001
CONTACT
AstraZeneca Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.