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

OmicsWay

Status

Unknown

Conditions

HER2-positive Breast Cancer

Treatments

Other: Transcriptome analysis

Drug: Chemotherapy

Other: RNA sequencing

Drug: Trastuzumab

Study type

Observational

Funder types

Industry

Other

Identifiers

NCT03521245

OB0012018

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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