HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a) (HER2-PREDICT)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain
- Hospital Universitari Vall d' Hebron
-
Barcelona, Spain
- ICO Hospitalet
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Madrid, Spain
- Hospital Universitario 12 de Octubre
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Murcia, Spain, 30120
- Hospital Universitario Virgen de La Arrixaca
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Málaga, Spain
- Hospital Virgen de la Victoria
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Seville, Spain
- Hospital Universitario Virgen del Rocio
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Barcelona
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Badalona, Barcelona, Spain
- ICO Badalona
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Barcelona, Barcelona, Spain, 08036
- Hospital Clínic de Barcelona
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Barcelona, Barcelona, Spain, 08003
- Hospital del Mar
-
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Cadiz
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Jerez de la Frontera, Cadiz, Spain, 11407
- Hospital Universitario de Jerez
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Canary Islands
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Santa Cruz de Tenerife, Canary Islands, Spain, 38320
- Hospital Universitario de Canarias
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Lleida
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Lleida, Lleida, Spain
- H.Univ. Arnau de Vilanova de Lleida
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Madrid
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Madrid, Madrid, Spain, 28046
- Hospital La Paz
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-
Sevilla
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Seville, Sevilla, Spain
- Hospital Virgen de Macarena
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Valencia
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Valencia, Valencia, Spain, 46009
- Instituto Valenciano de Oncología (IVO)
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
A. Inclusion Criteria
- Women and men ≥18 years old that has been included in a trial using Trastuzumab Deruxtecan (T-DXd; DS-8201a).
- 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.
- Patients who are starting, are receiving or have received treatment with Trastuzumab Deruxtecan as a treatment for metastatic/advanced cancer.
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.
- 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.
- Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
Patients included before starting experimental treatment must be able and willing to provide blood sample(s).
B. Exclusion Criteria
- Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan.
- Inability to comply with study and follow-up procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Experimental Arm
Patients with metastatic cancer treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOLTI-1804
- 2019-002991-15 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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