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| Name | Class |
|---|---|
| Oncobox Ltd., Russia | UNKNOWN |
| Vitamed LLC, Russia | UNKNOWN |
| Republican Oncological Dispensary of Karelia Republic, Russia | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab monotherapy | Her2-positive breast cancer patients treated with Trastuzumab (monotherapy) |
| |
| Chemotherapy plus Trastuzumab | Her2-positive breast cancer patients treated with Trastuzumab in combination with other regimens of chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNA sequencing | Other | Next Generation Sequencing of RNA from tumor samples, rRNA-depleted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Residents of North-Western and Central Parts of Russian Federation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OmicsWay Corp. | Walnut | California | 91789 | United States | ||
| Republican Oncological Dispensary of the Ministry of Healthcare of Karelia Republic |
Study Protocol Statistical Analysis Plan (SAP) NGS data Clinical Study Report (CSR)
Beginning 3 months after trial completion, no end date
Anyone
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017423 | Sequence Analysis, RNA |
| D000081246 | RNA-Seq |
| D020869 | Gene Expression Profiling |
| D000068878 | Trastuzumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D017421 | Sequence Analysis |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
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Formalin-fixed, paraffin embedded pathological samples of breast cancer obtained during radical mastectomy or core needle biopsy
| Transcriptome analysis | Other | Analysis of RNA-seq data using the Oncobox algorithm. |
|
| Trastuzumab | Drug | Standard Trastuzumab treatment regimen recommended for breast cancer |
|
| Chemotherapy | Drug | Standard chemotherapy regimen recommended for breast cancer |
|
| Petrozavodsk |
| Karelia Republic |
| 185007 |
| Russia |
| Vitamed LLC | Moscow | 121309 | Russia |
| "Oncobox" Ltd. | Moscow | 143026 | Russia |
| D017437 |
| Skin and Connective Tissue Diseases |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013812 | Therapeutics |