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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Cancer
• Intervention / Treatment: Other: Tumor and Blood sample collection

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d' Hebrón
  • Barcelona, Spain
    • ICO Hospitalet
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de la Arrixaca
  • Málaga, Spain
    • Hospital Virgen de la Victoria
  • Seville, Spain
    • Hospital Universitario Virgen del Rocio
  • Barcelona
    • Badalona, Barcelona, Spain
      • Ico Badalona
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic De Barcelona
    • Barcelona, Barcelona, Spain, 08003
      • Hospital del Mar
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11407
      • Hospital Universitario de Jerez
  • Canary Islands
    • Santa Cruz de Tenerife, Canary Islands, Spain, 38320
      • Hospital Universitario de Canarias
  • Lleida
    • Lleida, Lleida, Spain
      • H.Univ. Arnau de Vilanova de Lleida
  • Madrid
    • Madrid, Madrid, Spain, 28046
      • Hospital La Paz
  • Sevilla
    • Seville, Sevilla, Spain
      • Hospital Virgen de Macarena
  • Valencia
    • Valencia, Valencia, Spain, 46009
      • Instituto Valenciano de Oncología (IVO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Experimental Arm; Patients with metastatic cancer treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)	Other: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SOLTI Breast Cancer Research Group
• Collaborators: Daiichi Sankyo

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2019
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Investigative Techniques; Body Weights and Measures; Anthropometry; Tumor Burden
• Other Study ID Numbers: SOLTI-1804; 2019-002991-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No