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| Name | Class |
|---|---|
| Foundation Medicine | INDUSTRY |
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This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Breast Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Biopsy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| molecular analysis of metastatic breast cancer using DNA sequencing | The primary goal is to survey the known DNA abnormalities with potential therapeutic relevance in cancer and steer patients to therapies that target the detected abnormalities. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a metastatic breast cancer tissues resource for future research | The secondary objective is to establish a metastatic breast cancer tissues resource for future research to learn about biological events that drive metastatic cancer and to identify novel therapeutic targets and predictors of response to therapy. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent
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Metastatic Breast Cancer
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| Name | Affiliation | Role |
|---|---|---|
| Lajos Pusztai, M.D., D.Phil | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Hospital Breast Center | New Haven | Connecticut | 06520-8032 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Biopsies of metastatic cancer
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |