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

Sponsor
OmicsWay Corp. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03521245
Collaborator
Oncobox Ltd., Russia (Other), Vitamed LLC, Russia (Other), Republican Oncological Dispensary of Karelia Republic, Russia (Other)
40
Enrollment
4
Locations
55
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OmicsWay Corp. Walnut California United States 91789
    2 Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic Petrozavodsk Karelia Republic Russian Federation 185007
    3 Vitamed LLC Moscow Russian Federation 121309
    4 "Oncobox" Ltd. Moscow Russian Federation 143026

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anton A. Buzdin, Chief Scientific Officer, OmicsWay Corp.
    ClinicalTrials.gov Identifier:
    NCT03521245
    Other Study ID Numbers:
    • OB0012018
    First Posted:
    May 11, 2018
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Anton A. Buzdin, Chief Scientific Officer, OmicsWay Corp.
    breast cancer
    epidermal growth factor receptor
    HER2
    EGFR
    biomarkers
    targeted therapy
    NGS
    RNAseq
    mRNA
    transcriptome analysis
    signaling pathway
    intracellular molecular pathway
    Oncobox
    trastuzumab
    Additional relevant MeSH terms:
    Breast Neoplasms
    Trastuzumab

    Study Results

    No Results Posted as of Sep 14, 2021