Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma (NOS) | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gall Bladder Cancer | — | UNRESOLVED | — |
| Gastrointestinal Stromal Tumour | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Trastuzumab deruxtecan
- description
- 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
- interventionNames
- Drug: Trastuzumab deruxtecan
Primary outcomes (2)
- measure
- Real world response rate (rwRR)
- timeFrame
- Through study completion, up to 2.5 years after enrolment
- description
- rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment
- measure
- Real world duration of response (rwDoR)
- timeFrame
- Through study completion, up to 2.5 years after enrolment
- description
- rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available