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

Primary Purpose

Metastatic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tumor and Blood sample collection
Sponsored by
SOLTI Breast Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ICO BadalonaRecruiting
  • Hospital Universitario de JerezRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital del MarRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital Universitari Vall d' HebronRecruiting
  • ICO HospitaletRecruiting
  • H.Univ. Arnau de Vilanova de LleidaRecruiting
  • Hospital La Paz
  • Hospital Universitario 12 de octubre
  • Hospital Virgen de la VictoriaRecruiting
  • Hospital Universitario Virgen de la Arrixaca
  • Hospital Universitario Virgen del RocioRecruiting
  • Hospital Virgen de MacarenaRecruiting
  • Instituto Valenciano de Oncología (IVO)Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 30, 2020
Last Updated
January 23, 2023
Sponsor
SOLTI Breast Cancer Research Group
Collaborators
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04257162
Brief Title
HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Acronym
HER2-PREDICT
Official Title
HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOLTI Breast Cancer Research Group
Collaborators
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Arm
Arm Type
Other
Arm Description
Patients treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Intervention Type
Other
Intervention Name(s)
Tumor and Blood sample collection
Intervention Description
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 Measure Information:
Title
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
A. Inclusion Criteria 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). B. Exclusion Criteria Not having participated or not willing to participate in a trial using Trastuzumab Deruxtecan. Inability to comply with study and follow-up procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Canes Ruiz
Phone
933436302
Email
jordi.canes@gruposolti.org
Facility Information:
Facility Name
ICO Badalona
City
Badalona
State/Province
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanesa Quiroga Garcia, MD
Facility Name
Hospital Universitario de Jerez
City
Jerez De La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubén del Toro, MD
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Islas Canarias
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefina Cruz Jurado, MD
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Servitja Tormo Sonia, MD
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleix Prat
Facility Name
Hospital Universitari Vall d' Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Saura
Facility Name
ICO Hospitalet
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Pernas, MD
Facility Name
H.Univ. Arnau de Vilanova de Lleida
City
Lleida
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafín Morales, MD
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pilar Zamora, MD
Facility Name
Hospital Universitario 12 de octubre
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Ciruelos
First Name & Middle Initial & Last Name & Degree
Eva Ciruelos
Facility Name
Hospital Virgen de la Victoria
City
Malaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jose Bermejo Perez, MD
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerónimo Martínez
Phone
+34 968 36 93 87
Email
jeronimo@seom.org
First Name & Middle Initial & Last Name & Degree
Jerónimo Martínez
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Salvador Bofill, MD
Facility Name
Hospital Virgen de Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esteban Nogales Fernandez, MD
Facility Name
Instituto Valenciano de Oncología (IVO)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Mallol Roselló
Email
coordinacion@fincivo.org
First Name & Middle Initial & Last Name & Degree
Joaquin Gavilà Gregori

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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