UPCC 28825 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 (DP-04)

Investigating the Effectiveness of a Treatment for HER2-Positive Solid Tumors

Enrolling By Invitation
18 years - 130 years
All
Phase N/A
100 participants needed
1 Location

Brief description of 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

Detailed description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gall Bladder Cancer, Gastrointestinal Stromal Tumour, Head and Neck Cancer, Liver Cancer, Melanoma, Mouth Cancer, Nasopharangeal Cancer, Neuroendocrine, Gastrointestinal Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Renal Cell Carcinoma, Salivary Gland Cancer, Sarcoma, Small Cell Lung Cancer, Testicular Cancer, Throat Cancer, Thyroid Cancer, Urethral Cancer, Vaginal Cancer, Vulvar Cancer
  • Age: 18 years - 130 years
  • Gender: All

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

The purpose of this study is to investigate the effectiveness of an investigational medication in patients with HER2-positive solid tumors that are locally advanced, unresectable, or metastatic. In this study, HER2-positive is identified as IHC 3+. The study focuses on patients who have previously received systemic treatment for their condition but have no satisfactory alternative treatment options available.

This observational study involves about 100 patients who will be enrolled at the start of their treatment with the investigational medication. The study will take place at approximately 30 sites, including community oncology practices, hospital systems, and academic medical centers. The main procedures involve assessing the real-world response rate and duration of response to the investigational medication, as well as the time to treatment discontinuation and time to the next treatment.

  • Who can participate: Adults aged 18 years or older with HER2-positive (IHC 3+) solid tumors that are locally advanced, unresectable, or metastatic may participate. Participants must have received prior systemic treatment and have no satisfactory alternative treatment options. Certain cancers like breast, colorectal, NSCLC, and gastric/GEJ cancers are excluded.
  • Study details: Participants will receive an investigational medication as per the FDA label. They must provide signed informed consent and have HER2-positive status confirmed by local testing. The study does not involve any changes to their routine care but will observe their response to the treatment.
Updated on 22 Jul 2026. Study ID: 25-1566
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