NCT03521245

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

3.5 years

First QC Date

April 28, 2018

Last Update Submit

September 13, 2021

Conditions

HER2-positive Breast Cancer

Keywords

breast cancerepidermal growth factor receptorHER2EGFRbiomarkerstargeted therapyNGSRNAseqmRNAtranscriptome analysissignaling pathwayintracellular molecular pathwayOncoboxtrastuzumab

Outcome Measures

Primary Outcomes (1)

  • Tumor response by RECIST v1.1 or pathological response according to Chevallier system

    Tumor response by RECIST v1.1 or pathological response according to Chevallier system

    1 year

Study Arms (2)

Trastuzumab monotherapy

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

Other: RNA sequencingOther: Transcriptome analysisDrug: Trastuzumab

Chemotherapy plus Trastuzumab

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

Other: RNA sequencingOther: Transcriptome analysisDrug: TrastuzumabDrug: Chemotherapy

Interventions

RNA sequencingOTHER

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

Also known as: RNA-seq
Chemotherapy plus TrastuzumabTrastuzumab monotherapy
Transcriptome analysisOTHER

Analysis of RNA-seq data using the Oncobox algorithm.

Chemotherapy plus TrastuzumabTrastuzumab monotherapy
TrastuzumabDRUG

Standard Trastuzumab treatment regimen recommended for breast cancer

Chemotherapy plus TrastuzumabTrastuzumab monotherapy
ChemotherapyDRUG

Standard chemotherapy regimen recommended for breast cancer

Chemotherapy plus Trastuzumab

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of North-Western and Central Parts of Russian Federation

You may qualify if:

  • 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

You may not qualify if:

  • less than 70% of intact tumor cells in available FFPE samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

OmicsWay Corp.

Walnut, California, 91789, United States

Location

Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic

Petrozavodsk, Karelia Republic, 185007, Russia

Location

Vitamed LLC

Moscow, 121309, Russia

Location

"Oncobox" Ltd.

Moscow, 143026, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed, paraffin embedded pathological samples of breast cancer obtained during radical mastectomy or core needle biopsy

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sequence Analysis, RNARNA-SeqGene Expression ProfilingTrastuzumabDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative TechniquesHigh-Throughput Nucleotide SequencingAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Scientific Officer

Study Record Dates

First Submitted

April 28, 2018

First Posted

May 11, 2018

Study Start

October 1, 2017

Primary Completion

April 1, 2021

Study Completion

May 1, 2022

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months after trial completion, no end date
Access Criteria
Anyone

Locations

RU(3)US(1)