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

September 13, 2021 updated by: Anton A. Buzdin, OmicsWay Corp.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121309
        • VitaMed LLC
      • Moscow, Russian Federation, 143026
        • "Oncobox" Ltd.
    • Karelia Republic
      • Petrozavodsk, Karelia Republic, Russian Federation, 185007
        • Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic
  • United States
    • California
      • Walnut, California, United States, 91789
        • OmicsWay Corp.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Residents of North-Western and Central Parts of Russian Federation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Other: RNA sequencing
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
Other Names:
  • RNA-seq
Other: Transcriptome analysis
Analysis of RNA-seq data using the Oncobox algorithm.
Drug: Trastuzumab
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
Other: RNA sequencing
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
Other Names:
  • RNA-seq
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OmicsWay Corp.

Collaborators

Oncobox Ltd., Russia
Vitamed LLC, Russia
Republican Oncological Dispensary of Karelia Republic, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

April 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 28, 2018

First Submitted That Met QC Criteria

April 28, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB0012018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study Protocol Statistical Analysis Plan (SAP) NGS data Clinical Study Report (CSR)

IPD Sharing Time Frame

Beginning 3 months after trial completion, no end date

IPD Sharing Access Criteria

Anyone

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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