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

NCT04257162 | Active Not Recruiting

• 2 other identifiers: SOLTI-18042019-002991-15
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 15

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response

  through study completion, an average of 1 year

Study Arms (1)

Experimental Arm

OTHER

Patients with metastatic cancer treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)

Other: Tumor and Blood sample collection

Interventions

Tumor and Blood sample collection OTHER

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan.
• Inability to comply with study and follow-up procedures

Sponsors & Collaborators

• SOLTI Breast Cancer Research Group: lead
• Daiichi Sankyo: collaborator

Study Sites (15)

ICO Badalona

Badalona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitario de Jerez

Jerez de la Frontera, Cadiz, 11407, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

H.Univ. Arnau de Vilanova de Lleida

Lleida, Lleida, Spain

Location

Hospital La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Virgen de Macarena

Seville, Sevilla, Spain

Location

Instituto Valenciano de Oncología (IVO)

Valencia, Valencia, 46009, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Spain

Location

ICO Hospitalet

Barcelona, Spain

Location

Hospital Universitario 12 de octubre

Madrid, Spain

Location

Hospital Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Tumor Burden

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Weights and Measures; Anthropometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: December 13, 2019
• Primary Completion: June 30, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)