NCT03521245

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: OmicsWay Corp. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
OTHER	RNA sequencing	Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
OTHER	Transcriptome analysis	Analysis of RNA-seq data using the Oncobox algorithm.
DRUG	Trastuzumab	Standard Trastuzumab treatment regimen recommended for breast cancer
DRUG	Chemotherapy	Standard chemotherapy regimen recommended for breast cancer

Timeline

• Start date: 2017-10-01
• Primary completion: 2021-04-01
• Completion: 2022-05-01
• First posted: 2018-05-11
• Last updated: 2021-09-14

Locations

4 sites across 2 countries: United States, Russia

Regulatory

• FDA-regulated drug study