Clinical Trials Logo
  1. Home
  2. HER2-positive Breast Cancer
  3. NCT03521245
  4. Details
NCT03521245 Clinical Trial

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

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03521245
Other study ID # OB0012018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 1, 2022

Study information
Verified date September 2021
Source OmicsWay Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date May 1, 2022
Est. primary completion date April 1, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• RNA sequencing
Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
• Transcriptome analysis
Analysis of RNA-seq data using the Oncobox algorithm.
Drug:
• Trastuzumab
Standard Trastuzumab treatment regimen recommended for breast cancer
• Chemotherapy
Standard chemotherapy regimen recommended for breast cancer

Locations
Country Name City State
Russian Federation "Oncobox" Ltd. Moscow
Russian Federation Vitamed LLC Moscow
Russian Federation Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic Petrozavodsk Karelia Republic
United States OmicsWay Corp. Walnut California

Sponsors (4)
Lead Sponsor Collaborator
OmicsWay Corp. Oncobox Ltd., Russia, Republican Oncological Dispensary of Karelia Republic, Russia, Vitamed LLC, Russia

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Recruiting NCT04578106 - Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy Phase 2
Completed NCT01855828 - Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer Phase 2
Terminated NCT01912963 - Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Recruiting NCT04094896 - TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Recruiting NCT05346861 - Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab Phase 3
Completed NCT03330561 - PRS-343 in HER2-Positive Solid Tumors Phase 1
Recruiting NCT04997798 - Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer Phase 2
Not yet recruiting NCT04034823 - KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer Phase 2
Completed NCT04756921 - 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Completed NCT03140553 - TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Completed NCT03094052 - Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib Phase 2
Recruiting NCT05511844 - Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors Phase 1
Recruiting NCT05325632 - Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab Phase 2
Recruiting NCT06161922 - Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Recruiting NCT05710666 - Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study) Phase 2
Not yet recruiting NCT05063643 - Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude