HER2-positive Breast CancerNCT03521245
Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
An observational study of HER2-positive Breast Cancer, run by OmicsWay Corp. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- RNA sequencing, Transcriptome analysis and Trastuzumab
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2017to 1 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Adult, Older adult
Study population: Residents of North-Western and Central Parts of Russian Federation
Who may be able to join
- 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
Who cannot join
- less than 70% of intact tumor cells in available FFPE samples
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Russia3 sites
Vitamed LLC
Moscow, 121309
"Oncobox" Ltd.
Moscow, 143026
Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic
Petrozavodsk, Karelia Republic, 185007
About this study
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.
Read the 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.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- RNA sequencing, Transcriptome analysis, Trastuzumab, Chemotherapy
- Keywords
- breast cancer, epidermal growth factor receptor, HER2, EGFR, biomarkers, targeted therapy, NGS, RNAseq, mRNA, transcriptome analysis, signaling pathway, intracellular molecular pathway, Oncobox, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA sequencingOther
Also called RNA-seq
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
Transcriptome analysisOther
Analysis of RNA-seq data using the Oncobox algorithm.
TrastuzumabDrug
Standard Trastuzumab treatment regimen recommended for breast cancer
ChemotherapyDrug
Standard chemotherapy regimen recommended for breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab monotherapy | Her2-positive breast cancer patients treated with Trastuzumab (monotherapy) Receives: Other: RNA sequencing; Other: Transcriptome analysis; Drug: Trastuzumab | |
| Chemotherapy plus Trastuzumab | Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy Receives: Other: RNA sequencing; Other: Transcriptome analysis; Drug: Trastuzumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Oct 2017
- Primary completion1 Apr 2021
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OmicsWay Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oncobox Ltd., Russia, Vitamed LLC, Russia, Republican Oncological Dispensary of Karelia Republic, Russia
- Responsible party
- Principal investigator, Anton A. Buzdin, OmicsWay Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521245
- Sponsor's protocol ID
- OB0012018
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) NGS data Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03521245
- Acronym / sponsor ID
- OB0012018
- Conditions
- HER2-positive Breast Cancer
- Keywords
- breast cancer, epidermal growth factor receptor, HER2, EGFR, biomarkers, targeted therapy, NGS, RNAseq
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- OmicsWay Corp.Industry (pharma, biotech, devices)
- Collaborators
- Oncobox Ltd., Russia, Vitamed LLC, Russia, Republican Oncological Dispensary of Karelia Republic, Russia
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab monotherapy | – | Other: RNA sequencing, Other: Transcriptome analysis, Drug: TrastuzumabHer2-positive breast cancer patients treated with Trastuzumab (monotherapy) |
| Chemotherapy plus Trastuzumab | – | Other: RNA sequencing, Other: Transcriptome analysis, Drug: Trastuzumab, Drug: ChemotherapyHer2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Residents of North-Western and Central Parts of Russian Federation
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- less than 70% of intact tumor cells in available FFPE samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA sequencingAlso: RNA-seqNext Generation Sequencing of RNA from tumor samples, rRNA-depleted. | Other | Chemotherapy plus Trastuzumab, Trastuzumab monotherapy |
| Transcriptome analysisAnalysis of RNA-seq data using the Oncobox algorithm. | Other | Chemotherapy plus Trastuzumab, Trastuzumab monotherapy |
| TrastuzumabStandard Trastuzumab treatment regimen recommended for breast cancer | Drug | Chemotherapy plus Trastuzumab, Trastuzumab monotherapy |
| ChemotherapyStandard chemotherapy regimen recommended for breast cancer | Drug | Chemotherapy plus Trastuzumab |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) NGS data Clinical Study Report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by OmicsWay Corp. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Russia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response by RECIST v1.1 or pathological response according to Chevallier system (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.