Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- RNA sequencing
- Conditions
- HER2-positive Breast Cancer
- Sponsor
- OmicsWay Corp.
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Tumor response by RECIST v1.1 or pathological response according to Chevallier system
- Last Updated
- 4 years ago
Overview
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.
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.
Investigators
Anton A. Buzdin
Chief Scientific Officer
OmicsWay Corp.
Eligibility Criteria
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
Arms & Interventions
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Intervention: RNA sequencing
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Intervention: Transcriptome analysis
Trastuzumab monotherapy
Her2-positive breast cancer patients treated with Trastuzumab (monotherapy)
Intervention: Trastuzumab
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Intervention: RNA sequencing
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Intervention: Transcriptome analysis
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Intervention: Trastuzumab
Chemotherapy plus Trastuzumab
Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy
Intervention: Chemotherapy
Outcomes
Primary Outcomes
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