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

Not Applicable

Active, not recruiting

• Conditions: Metastatic Cancer

• Registration Number: NCT04257162
• Lead Sponsor: SOLTI Breast Cancer Research Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-13
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Primary Completion: 2025-06-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-02
• Last Update Posted: 2025-09-09
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (15)

ICO Badalona; 🇪🇸 Badalona, Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Barcelona, Spain

Hospital Universitario de Jerez; 🇪🇸 Jerez de la Frontera, Cadiz, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Canary Islands, Spain

H.Univ. Arnau de Vilanova de Lleida; 🇪🇸 Lleida, Lleida, Spain

Hospital La Paz; 🇪🇸 Madrid, Madrid, Spain

Hospital Virgen de Macarena; 🇪🇸 Seville, Sevilla, Spain

Instituto Valenciano de Oncología (IVO); 🇪🇸 Valencia, Valencia, Spain

Hospital Universitari Vall d' Hebron; 🇪🇸 Barcelona, Spain

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