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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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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

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HER2-positive Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Trastuzumab monotherapy

Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)

RNA sequencing

Intervention Type OTHER

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

Transcriptome analysis

Intervention Type OTHER

Analysis of RNA-seq data using the Oncobox algorithm.

Trastuzumab

Intervention Type DRUG

Standard Trastuzumab treatment regimen recommended for breast cancer

Chemotherapy plus Trastuzumab

Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy

RNA sequencing

Intervention Type OTHER

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

Transcriptome analysis

Intervention Type OTHER

Analysis of RNA-seq data using the Oncobox algorithm.

Trastuzumab

Intervention Type DRUG

Standard Trastuzumab treatment regimen recommended for breast cancer

Chemotherapy

Intervention Type DRUG

Standard chemotherapy regimen recommended for breast cancer

Interventions

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RNA sequencing

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

Intervention Type OTHER

Transcriptome analysis

Analysis of RNA-seq data using the Oncobox algorithm.

Intervention Type OTHER

Trastuzumab

Standard Trastuzumab treatment regimen recommended for breast cancer

Intervention Type DRUG

Chemotherapy

Standard chemotherapy regimen recommended for breast cancer

Intervention Type DRUG

Other Intervention Names

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RNA-seq

Eligibility Criteria

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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