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

January 23, 2023 updated by: SOLTI Breast Cancer Research Group
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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
        • Principal Investigator:
          • Servitja Tormo Sonia, MD
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
          • Aleix Prat
      • Barcelona, Spain
        • Recruiting
        • ICO Hospitalet
        • Principal Investigator:
          • Sonia Pernas, MD
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d' Hebron
        • Contact:
          • Cristina Saura
      • Lleida, Spain
        • Recruiting
        • H.Univ. Arnau de Vilanova de Lleida
        • Principal Investigator:
          • Serafín Morales, MD
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Eva Ciruelos
      • Madrid, Spain, 28046
        • Not yet recruiting
        • Hospital La Paz
        • Principal Investigator:
          • Pilar Zamora, MD
      • Malaga, Spain
        • Recruiting
        • Hospital Virgen de la Victoria
        • Principal Investigator:
          • Maria Jose Bermejo Perez, MD
      • Murcia, Spain, 30120
        • Not yet recruiting
        • Hospital Universitario Virgen de la Arrixaca
        • Contact:
        • Principal Investigator:
          • Jerónimo Martínez
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Principal Investigator:
          • Javier Salvador Bofill, MD
      • Sevilla, Spain
        • Recruiting
        • Hospital Virgen de Macarena
        • Principal Investigator:
          • Esteban Nogales Fernandez, MD
      • Valencia, Spain, 46009
        • Recruiting
        • Instituto Valenciano de Oncología (IVO)
        • Contact:
        • Principal Investigator:
          • Joaquin Gavilà Gregori
    • Barcelona
      • Badalona, Barcelona, Spain
        • Recruiting
        • Ico Badalona
        • Principal Investigator:
          • Vanesa Quiroga Garcia, MD
    • Cadiz
      • Jerez De La Frontera, Cadiz, Spain, 11407
        • Recruiting
        • Hospital Universitario De Jerez
        • Principal Investigator:
          • Rubén del Toro, MD
    • Islas Canarias
      • Tenerife, Islas Canarias, Spain, 38320
        • Recruiting
        • Hospital Universitario de Canarias
        • Principal Investigator:
          • Josefina Cruz Jurado, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 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
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOLTI Breast Cancer Research Group

Collaborators

Daiichi Sankyo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2019

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

December 15, 2024

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 (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

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)?

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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