DESTINY-PANTUMOUR04
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab deruxtecan.
- Who it may be relevant to
- Registry conditions: Adenocarcinoma (NOS), Anal Cancer, Bladder Cancer, Cervical Cancer. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Trastuzumab deruxtecan
Trastuzumab deruxtecan monotherapy
Primary outcome measures
- Real world response rate (rwRR) [Time frame: Through study completion, up to 2.5 years after enrolment]
- Real world duration of response (rwDoR) [Time frame: Through study completion, up to 2.5 years after enrolment]
Secondary outcome measures (2)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- Research Site — Birmingham
- Research Site — Bullhead City
- Research Site — Casa Grande
- Research Site — San Diego
- Research Site — Boulder
- Research Site — Coral Springs
- Research Site — St. Petersburg
- Research Site — West Palm Beach
- … and 10 more centers
Identifiers
NCT: NCT07124000 · D781WR00001