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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03521245

Enrollment

Registered

2018-05-11

Start date

2017-10-01

Completion date

2022-05-01

Last updated

2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer

Keywords

breast cancer, epidermal growth factor receptor, HER2, EGFR, biomarkers, targeted therapy, NGS, RNAseq, mRNA, transcriptome analysis, signaling pathway, intracellular molecular pathway, Oncobox, trastuzumab

Brief 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.

Interventions

OTHERRNA sequencing

Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.

OTHERTranscriptome analysis

Analysis of RNA-seq data using the Oncobox algorithm.

DRUGTrastuzumab

Standard Trastuzumab treatment regimen recommended for breast cancer

DRUGChemotherapy

Standard chemotherapy regimen recommended for breast cancer

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor response by RECIST v1.1 or pathological response according to Chevallier system	1 year	Tumor response by RECIST v1.1 or pathological response according to Chevallier system

Countries

Russia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026