DESTINY-PANTUMOUR04
DP-04
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
1 other identifier
observational
100
1 country
17
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2025
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedStudy Start
First participant enrolled
September 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
June 1, 2026
May 1, 2026
2.5 years
August 13, 2025
May 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Real world response rate (rwRR)
rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment
Through study completion, up to 2.5 years after enrolment
Real world duration of response (rwDoR)
rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death
Through study completion, up to 2.5 years after enrolment
Secondary Outcomes (2)
Real world time to treatment discontinuation (rwTTD)
Through study completion, up to 2.5 years after enrolment
Real world time to next treatment (rwTTNT)
Through study completion, up to 2.5 years after enrolment
Study Arms (1)
Trastuzumab deruxtecan
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
Interventions
Trastuzumab deruxtecan monotherapy
Eligibility Criteria
The study will enroll patients 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, but who have not yet started therapy with T-DXd
You may qualify if:
- Adults aged ≥18 years
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (17)
Research Site
Birmingham, Alabama, 35243, United States
Research Site
Bullhead City, Arizona, 86442, United States
Research Site
Casa Grande, Arizona, 85122, United States
Research Site
San Diego, California, 92123, United States
Research Site
Boulder, Colorado, 80309, United States
Research Site
Coral Springs, Florida, 33065, United States
Research Site
St. Petersburg, Florida, 33714, United States
Research Site
West Palm Beach, Florida, 33401, United States
Research Site
Decatur, Illinois, 62526, United States
Research Site
Topeka, Kansas, 66604, United States
Research Site
Durham, North Carolina, 27708, United States
Research Site
Wilson, North Carolina, 27893, United States
Research Site
Canton, Ohio, 44718, United States
Research Site
Maumee, Ohio, 43537, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2025
First Posted
August 15, 2025
Study Start
September 18, 2025
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2028
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.