HER2-PREDICT: Translational Study of Tumor Samples From DS8201-A-U301 and DS8201-A-U302 Trials.

STATUS

Recruiting
participants needed

180
sponsor

SOLTI Breast Cancer Research Group

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Updated on 19 February 2024

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cancer

breast cancer

epidermal growth factor receptor

metastasis

formalin-fixed paraffin-embedded

bone metastases

core needle biopsy

primary tumor

stage iv breast cancer

erbb2

breast tumor

her-2

pleural effusion

fine needle aspiration

HER2

Summary

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This is a multi-center, observational study. Patients who will participate, are participating or have participated in Daichi Sankyo INC sponsored Ds8201-A-U301 and Ds8201-A-U302 trials will be asked to participate to HER2-PREDICT study offering them a new informed consent.

In order to identify mRNA ERBB2 levels, we will evaluate by gene expression tumor samples from these patients.

Description

After signing the informed consent form:

For patients who have already begun dosing in Daichi Sankyo INC sponsored Ds8201-A-U301 and Ds8201-A-U302 trials, an archival metastatic biopsy will be requested for inclusion purposes.
For patients who have not yet dosed in Daichi Sankyo INC sponsored Ds8201-A-U301 and Ds8201-A-U302 trials eligible patients will undergo a fresh biopsy of a metastatic site. If not feasible, archival sample from metastatic site will be accepted. Blood samples will be collected from eligible patients for biomarker analyses.

In both cases, a breast tumor sample will be acceptable for those patients who are diagnosed with de novo metastatic breast cancer.

Exceptionally, for those patients who do not have a metastatic sample or the possibility of obtaining it in the cases mentioned above, the possibility of sending a sample of the primary tumor for inclusion purposes may be requested. SOLTI will confirm if the patient can be included.

In order to identify mRNA ERBB2 levels, we will evaluate by gene expression tumor samples from these patients.

Details

Condition	Metastatic Breast Cancer
Age	18years - 100years
Treatment	Tumor and Blood sample collection
Clinical Study Identifier	NCT04257162
Sponsor	SOLTI Breast Cancer Research Group
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Women 18 years old who will participate, are participating or previously participated in Daichi Sankyo INC. sponsored Ds8201-A-U301, Ds8201-A-U302 trials, consented for the obtention of a fresh biopsy or for the donation of an archival metastatic biopsy may be enrolled
	a breast tumor sample will be acceptable for those patients who are diagnosed with de novo metastatic breast cancer
	Exceptionally, for those patients who do not have a metastatic sample or the possibility of obtaining it in the cases mentioned above, the possibility of sending a sample of the primary tumor for inclusion purposes may be requested. SOLTI will confirm if the patient can be included
	The participant (or legally acceptable representative if applicable) provides written informed consent for the study
	Fulfill all inclusion and exclusion criteria of the Ds8201-A-U301 or U302 trials prior to inclusion
	Availability of FFPE tumor block, collected prior to the inclusion in Ds8201-A- U301 or U302 trial, with an associated pathology report. The tumor tissue should be of good quality based on total and viable tumor content
	Acceptable samples include core needle biopsies for deep tumor tissue 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
	Must be able to provide blood sample(s)
Exclusion Criteria
	Not having participated or not willing to participate to the Daichi Sankyo INC. sponsored Ds8201-A-U301, Ds8201-A-U302 trials

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Step 2 Get screened

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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stage iv breast cancer

fine needle aspiration

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HER2-PREDICT: Translational Study of Tumor Samples From DS8201-A-U301 and DS8201-A-U302 Trials.