Adenocarcinoma (NOS)DP-04NCT07124000
DESTINY-PANTUMOUR04
An observational study of Adenocarcinoma (NOS) and Anal Cancer, run by AstraZeneca at 18 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer
- What is being tested?
- Trastuzumab deruxtecan
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- 18 Sep 2025to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
Research Site
Birmingham, Alabama, 35243
- Recruiting
Research Site
Boulder, Colorado, 80309
- Recruiting
Research Site
Bullhead City, Arizona, 86442
- Recruiting
Research Site
Canton, Ohio, 44718
- Recruiting
Research Site
Casa Grande, Arizona, 85122
- Recruiting
Research Site
Coral Springs, Florida, 33065
- Recruiting
Research Site
Dallas, Texas, 75390
- Recruiting
Research Site
Decatur, Illinois, 62526
- Recruiting
Research Site
Durham, North Carolina, 27708
- Recruiting
Research Site
Farmington, New Mexico, 87401
- Recruiting
Research Site
Maumee, Ohio, 43537
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
- Recruiting
Research Site
San Diego, California, 92123
- Recruiting
Research Site
St. Petersburg, Florida, 33714
- Recruiting
Research Site
Topeka, Kansas, 66604
- Recruiting
Research Site
West Palm Beach, Florida, 33401
- Recruiting
Research Site
Wilson, North Carolina, 27893
About this study
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
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
Read the 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
- Being tested
- Trastuzumab deruxtecan
- Medical subject headings
- Adenocarcinoma, Anus Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Gallbladder Neoplasms, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab deruxtecanDrug
Also called Enhertu
Trastuzumab deruxtecan monotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Trastuzumab deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, up to 2.5 years after enrolment
Secondary outcomes (2)
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
Measured: 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
Measured: Through study completion, up to 2.5 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start18 Sep 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma (NOS)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124000
- Sponsor's protocol ID
- D781WR00001
- Acronym
- DP-04
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07124000
- Acronym / sponsor ID
- DP-04 / D781WR00001
- Conditions
- Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab deruxtecan | – | Drug: Trastuzumab deruxtecanPatients 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 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab deruxtecanAlso: EnhertuTrastuzumab deruxtecan monotherapy | Drug | Trastuzumab deruxtecan |
Primary outcome
Real world response rate (rwRR)
Time frame: Through study completion, up to 2.5 years after enrolment
rwRR is defined as the proportion of patients with a clinician assessment of complete or partial response while on T-DXd treatment
Real world duration of response (rwDoR)
Time frame: Through study completion, up to 2.5 years after enrolment
rwDoR is defined as the time from first physician reported complete or partial response until time of progression or death
2 secondary outcomes
Real world time to treatment discontinuation (rwTTD)
Time frame: Through study completion, up to 2.5 years after enrolment
Real world time to next treatment (rwTTNT)
Time frame: Through study completion, up to 2.5 years after enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Adenocarcinoma (NOS)
Active, not recruitingPhase 2
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
Salivary Gland Cancer, Recurrent Salivary Gland Cancer
Enrolling by invitationObservational study
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Melanoma, Adenocarcinoma
Active, not recruitingPhase 3
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
Advanced Vaginal Adenocarcinoma, Advanced Vaginal Adenosquamous Carcinoma
Active, not recruitingPhase 2
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Androgen Receptor Positive, Locally Advanced Salivary Gland Carcinoma
RecruitingPhase 1
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
Pancreatic Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma (NOS) and Anal Cancer, run by AstraZeneca at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real world response rate (rwRR) (time frame: Through study completion, up to 2.5 years after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.