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

Metastatic Cancer Clinical Trial

— HER2-PREDICT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04257162
• Other study ID #: SOLTI-1804
• Secondary ID: 2019-002991-15
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2023
• Source: SOLTI Breast Cancer Research Group
• Contact: Jordi Canes Ruiz
• Phone: 933436302
• Email: jordi.canes[@]gruposolti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Spain	ICO Badalona	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d' Hebron	Barcelona
Spain	ICO Hospitalet	Barcelona
Spain	Hospital Universitario de Jerez	Jerez De La Frontera	Cadiz
Spain	H.Univ. Arnau de Vilanova de Lleida	Lleida
Spain	Hospital La Paz	Madrid
Spain	Hospital Universitario 12 de octubre	Madrid
Spain	Hospital Virgen de la Victoria	Malaga
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Virgen de Macarena	Sevilla
Spain	Hospital Universitario de Canarias	Tenerife	Islas Canarias
Spain	Instituto Valenciano de Oncología (IVO)	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
SOLTI Breast Cancer Research Group	Daiichi Sankyo, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify the optimal ERBB2 mRNA cut-point predictive of T-DXd response		through study completion, an average of 1 year