Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07124000

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adenocarcinoma (NOS) Adenocarcinoma Adnexal Diseases Anal Cancer Anus Diseases Anus Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Bladder Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Renal Cell Cervical Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gall Bladder Cancer Gallbladder Diseases Gallbladder Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Gastrointestinal Stromal Tumour Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Mouth Cancer Mouth Diseases Mouth Neoplasms Nasopharangeal Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Neuroendocrine, Gastrointestinal Cancer Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Cancer Salivary Gland Diseases Salivary Gland Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Stomatognathic Diseases Testicular Cancer Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Throat Cancer Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urethral Cancer Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Trastuzumab Deruxtecan

Drug

Trastuzumab deruxtecan monotherapy

Other names: Enhertu

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Real world time to treatment discontinuation (rwTTD)

    Time frame: Through study completion, up to 2.5 years after enrolment

    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

  2. Real world time to next treatment (rwTTNT)

    Time frame: Through study completion, up to 2.5 years after enrolment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: DP-04

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 15, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.