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

Sponsor

SOLTI Breast Cancer Research Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT04257162

Collaborator

Daiichi Sankyo, Inc. (Industry)

180

Enrollment

Locations

Arm

48.1

Anticipated Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Other: Tumor and Blood sample collection	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 13, 2019

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICO Badalona	Badalona	Barcelona	Spain
2	Hospital Universitario de Jerez	Jerez De La Frontera	Cadiz	Spain	11407
3	Hospital Universitario de Canarias	Tenerife	Islas Canarias	Spain	38320
4	Hospital del Mar	Barcelona		Spain	08003
5	Hospital Clínic de Barcelona	Barcelona		Spain	08036
6	Hospital Universitari Vall d' Hebron	Barcelona		Spain
7	ICO Hospitalet	Barcelona		Spain
8	H.Univ. Arnau de Vilanova de Lleida	Lleida		Spain
9	Hospital La Paz	Madrid		Spain	28046
10	Hospital Universitario 12 de octubre	Madrid		Spain
11	Hospital Virgen de la Victoria	Malaga		Spain
12	Hospital Universitario Virgen de la Arrixaca	Murcia		Spain	30120
13	Hospital Universitario Virgen del Rocio	Sevilla		Spain
14	Hospital Virgen de Macarena	Sevilla		Spain
15	Instituto Valenciano de Oncología (IVO)	Valencia		Spain	46009

Sponsors and Collaborators

SOLTI Breast Cancer Research Group
Daiichi Sankyo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SOLTI Breast Cancer Research Group

ClinicalTrials.gov Identifier:

NCT04257162

Other Study ID Numbers:

SOLTI-1804
2019-002991-15

First Posted:

Feb 5, 2020

Last Update Posted:

Nov 1, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of Nov 1, 2021