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NCT03521245 Clinical Trial

Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03521245
Other study ID # OB0012018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 1, 2022

Study information
Verified date September 2021
Source OmicsWay Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to identify molecular markers at the level of molecular pathway activation to predict efficacy of anti-HER2 therapy with Trastuzumab.

Description:

Biopsy and/or surgical samples from Her2-positive breast cancer patients treated with Trastuzumab alone or in combinations with other regimens of chemotherapy with known clinical outcomes will be collected and subjected to mRNA sequencing. Expression profiles will be analysed using original bioinformatic platform Oncobox. Based on comparison of molecular pathways activation strength and clinical response to Trastuzumab and chemotherapy, this study aims to identify molecular markers predicting efficacy of therapy with Trastuzumab and the possibility of further relapse.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date May 1, 2022
Est. primary completion date April 1, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - adult females - histologically confirmed HER2-positive breast cancer - available FFPE samples of breast cancer tissue - patients treated with Trastuzumab alone or in combination(s) with other regimens of chemotherapy with known outcome according to RECIST 1.1 - stage II or more - patients who have signed an informed consent Exclusion Criteria: - less than 70% of intact tumor cells in available FFPE samples

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• RNA sequencing
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
• Transcriptome analysis
Analysis of RNA-seq data using the Oncobox algorithm.
Drug:
• Trastuzumab
Standard Trastuzumab treatment regimen recommended for breast cancer
• Chemotherapy
Standard chemotherapy regimen recommended for breast cancer

Locations
Country Name City State
Russian Federation "Oncobox" Ltd. Moscow
Russian Federation Vitamed LLC Moscow
Russian Federation Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic Petrozavodsk Karelia Republic
United States OmicsWay Corp. Walnut California

Sponsors (4)
Lead Sponsor Collaborator
OmicsWay Corp. Oncobox Ltd., Russia, Republican Oncological Dispensary of Karelia Republic, Russia, Vitamed LLC, Russia

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor response by RECIST v1.1 or pathological response according to Chevallier system Tumor response by RECIST v1.1 or pathological response according to Chevallier system 1 year
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