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Active, not recruiting Not applicable

HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)

NCT04257162 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2019-12-13
Last updated
2025-09-09

Condition(s) studied

Metastatic Cancer

Investigational drug(s) / intervention(s)

Tumor and Blood sample collection

Tumor and Blood sample collection: This is a non-interventional protocol and does not provide study drug or specific requirements for how the patients should be treated. Nevertheless, patients participating in T-DXd trials included in this study are those who were randomized to receive T-DXd. Tumor sample and blood sample will be collected within the framework of HER2-Predict Study

Study summary

HER2-Predict is a multi-center, observational study using biological samples from patients treated with DS-8201a in the metastatic setting. Patients will provide a baseline FFPE tumor sample and additionally, blood sample for ctDNA determination will be collected.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
A. Inclusion Criteria 1. Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a). 2. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. It is possible to include patients that were exitus during or after treatment by filling out the appendix 1 form and filing it into the patient's clinical chart. 3. Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer. 4. Submission of a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block from the most recently collected tumor tissue, with an associated pathology report, for central molecular analysis and for other protocol-mandated secondary and exploratory assessments. If a newer specimen is either insufficient or unavailable, the patient may still be eligible if the patient can provide a tissue block (preferred) or is willing to consent to and undergo an additional pretreatment core or excisional biopsy (if it is assessable and the biopsy can be safely obtained). The tumor tissue should be of good quality and quantity based on total and viable tumor content. 1. Acceptable samples include core needle biopsies of the deep metastatic lesion or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases. 2. Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable. 5. Patients included before starting experimental treatment must be able and willing to provide blood sample(s). B. Exclusion Criteria 6. Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan. 7. Inability to comply with study and follow-up procedures

Primary outcome measure(s)

  • identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response — through study completion, an average of 1 year

Trial sites (15)

FacilityCityRegionStatus
ICO Badalona Badalona Barcelona
Hospital del Mar Barcelona Barcelona
Hospital Clínic de Barcelona Barcelona Barcelona
Hospital Universitario de Jerez Jerez de la Frontera Cadiz
Hospital Universitario de Canarias Santa Cruz de Tenerife Canary Islands
H.Univ. Arnau de Vilanova de Lleida Lleida Lleida
Hospital La Paz Madrid Madrid
Hospital Virgen de Macarena Seville Sevilla
Instituto Valenciano de Oncología (IVO) Valencia Valencia
Hospital Universitari Vall d' Hebron Barcelona Spain
ICO Hospitalet Barcelona Spain
Hospital Universitario 12 de octubre Madrid Spain
Hospital Virgen de la Victoria Málaga Spain
Hospital Universitario Virgen de la Arrixaca Murcia Spain
Hospital Universitario Virgen del Rocio Seville Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04257162 on ClinicalTrials.gov ↗ ← All trials in Spain