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2025-08-31
2028-02-28
2028-02-28
100
NCT07124000
AstraZeneca
AstraZeneca
OBSERVATIONAL
DESTINY-PANTUMOUR04
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
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-08-13 | N/A | 2025-08-13 |
2025-08-13 | N/A | 2025-08-15 |
2025-08-15 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 | DRUG: Trastuzumab deruxtecan
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Real world time to treatment discontinuation (rwTTD) | rwTTD is defined as the time from first administration of T-DXd to the date of the clinican decision to discontinue treatment with T-DXd or patient death while on T-DXd therapy | Through study completion, up to 2.5 years after enrolment |
| Real world time to next treatment (rwTTNT) | rwTTNT is defined as the time from the date of first administration of T-DXd to the date of first administration of the next line of treatment or death | Through study completion, up to 2.5 years after enrolment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: AstraZeneca Clinical Study Information Center Phone Number: 1-877-240-9479 Email: information.center@astrazeneca.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
