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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04257162
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : November 1, 2021
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Other: Tumor and Blood sample collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Actual Study Start Date : December 13, 2019
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response [ Time Frame: through study completion, an average of 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04257162

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Contact: Jordi Canes Ruiz 933436302

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ICO Badalona Recruiting
Badalona, Barcelona, Spain
Principal Investigator: Vanesa Quiroga Garcia, MD         
Hospital Universitario de Jerez Recruiting
Jerez De La Frontera, Cadiz, Spain, 11407
Principal Investigator: Rubén del Toro, MD         
Hospital Universitario de Canarias Recruiting
Tenerife, Islas Canarias, Spain, 38320
Principal Investigator: Josefina Cruz Jurado, MD         
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Principal Investigator: Servitja Tormo Sonia, MD         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Aleix Prat         
Hospital Universitari Vall d' Hebron Recruiting
Barcelona, Spain
Contact: Cristina Saura         
ICO Hospitalet Recruiting
Barcelona, Spain
Principal Investigator: Sonia Pernas, MD         
H.Univ. Arnau de Vilanova de Lleida Recruiting
Lleida, Spain
Principal Investigator: Serafín Morales, MD         
Hospital La Paz Not yet recruiting
Madrid, Spain, 28046
Principal Investigator: Pilar Zamora, MD         
Hospital Universitario 12 de octubre Not yet recruiting
Madrid, Spain
Contact: Eva Ciruelos         
Principal Investigator: Eva Ciruelos         
Hospital Virgen de la Victoria Recruiting
Malaga, Spain
Principal Investigator: Maria Jose Bermejo Perez, MD         
Hospital Universitario Virgen de la Arrixaca Not yet recruiting
Murcia, Spain, 30120
Contact: Jerónimo Martínez    +34 968 36 93 87   
Principal Investigator: Jerónimo Martínez         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Javier Salvador Bofill, MD         
Hospital Virgen de Macarena Recruiting
Sevilla, Spain
Principal Investigator: Esteban Nogales Fernandez, MD         
Instituto Valenciano de Oncología (IVO) Recruiting
Valencia, Spain, 46009
Contact: Pedro Mallol Roselló   
Principal Investigator: Joaquin Gavilà Gregori         
Sponsors and Collaborators
SOLTI Breast Cancer Research Group
Daiichi Sankyo, Inc.
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Responsible Party: SOLTI Breast Cancer Research Group Identifier: NCT04257162    
Other Study ID Numbers: SOLTI-1804
2019-002991-15 ( EudraCT Number )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes