Trials / Recruiting
RecruitingNCT07124000
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This study is a multicenter, hybrid, observational study of approximately 100 prospectively enrolled patients with HER2-positive (IHC 3+) solid tumors in the US initiated on trastuzumab deruxtecan (T-DXd) as per FDA label in routine clinical practice and enrolled at the point of starting treatment with T-DXd. 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 will be eligible for inclusion. Patients with breast, colorectal, non-small cell lung cancer (NSCLC), gastric/gastroesophageal junction (GEJ) cancers, and haematological malignancies are not eligible for this study. Approximately 30 sites will be selected including community oncology practices, hospital systems and academic medical centers (AMCs), with a focus on enrolling a patient population representative of real-world care with the majority of patients from community settings. The primary objective of the study is to assess real world response rate and real world duration of response, and the secondary objective is to assess real world time to treatment discontinuation and real world time to next treatment.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Trastuzumab deruxtecan | Trastuzumab deruxtecan monotherapy |
Timeline
- Start date
- 2025-09-18
- Primary completion
- 2028-03-30
- Completion
- 2028-03-30
- First posted
- 2025-08-15
- Last updated
- 2026-03-31
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07124000. Inclusion in this directory is not an endorsement.