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The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Therapy | Experimental | Those who will receive targeted therapy based on their genetic profiling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genetic profiling | Genetic | genetic profiling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessment | Radiographic response will be evaluated according to RECIST 1.1 criteria in all patients with measurable disease. All sites of disease must be evaluated using the baseline assessment methods. Confirmatory assessment of complete response or partial response must be performed no less than 4 weeks after the initial documentation of response. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Leyland-Jones, MD | Avera McKennan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
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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 |
|---|---|
| D016172 | DNA Fingerprinting |
| ID | Term |
|---|---|
| D056667 | Biometric Identification |
| D001699 | Biometry |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 |
| Investigative Techniques |
| D005821 | Genetic Techniques |
| D012637 | Security Measures |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |