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

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ClinicalTrials.gov Identifier: NCT04257162
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : November 1, 2021
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
SOLTI Breast Cancer Research Group

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date November 1, 2021
Actual Study Start Date  ICMJE December 13, 2019
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2021)
identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response [ Time Frame: through study completion, an average of 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2020)
identify the optimal ERBB2 mRNA cut-point predictive of DS-8201 response [ Time Frame: through study completion, an average of 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Official Title  ICMJE HER2-PREDICT: Translational Study of Tumor Samples From Patients Treated With Trastuzumab Deruxtecan (T-DXd; DS-8201a)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Metastatic Cancer
Intervention  ICMJE 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

Study Arms  ICMJE Experimental Arm
Patients treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Intervention: Other: Tumor and Blood sample collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2020)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2023
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jordi Canes Ruiz 933436302 jordi.canes@gruposolti.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04257162
Other Study ID Numbers  ICMJE SOLTI-1804
2019-002991-15 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SOLTI Breast Cancer Research Group
Study Sponsor  ICMJE SOLTI Breast Cancer Research Group
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE Not Provided
PRS Account SOLTI Breast Cancer Research Group
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP