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| Name | Class |
|---|---|
| Side-Out Foundation | OTHER |
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The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.
To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Breast Cancer Patients | Other | Blood drawn for molecular profiling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Approved therapy will be assigned based on molecular profile and RPMA results | Drug | treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results |
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| Measure | Description | Time Frame |
|---|---|---|
| Growth Modulation Index (GMI) Greater Than or Equal to 1.3 | The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful. | 6-20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gayle Jameson, RNMSNACNP-BC | Scottsdale Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tgen Clinical Research Services | Scottsdale | Arizona | 85258 | United States | ||
| Fairfax North Virginia Hematology Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25209003 | Derived | Jameson GS, Petricoin EF, Sachdev J, Liotta LA, Loesch DM, Anthony SP, Chadha MK, Wulfkuhle JD, Gallagher RI, Reeder KA, Pierobon M, Fulk MR, Cantafio NA, Dunetz B, Mikrut WD, Von Hoff DD, Robert NJ. A pilot study utilizing multi-omic molecular profiling to find potential targets and select individualized treatments for patients with previously treated metastatic breast cancer. Breast Cancer Res Treat. 2014 Oct;147(3):579-88. doi: 10.1007/s10549-014-3117-1. Epub 2014 Sep 11. |
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The open-label multicenter pilot study accrued patients between March 2010 and June 2012. Three Oncology Practices contributed patients to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Breast Cancer Patients | Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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|
| Fairfax |
| Virginia |
| 22031 |
| United States |
| Evergreen Hematology and Oncology | Spokane | Washington | 99218 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Participants | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Growth Modulation Index (GMI) Greater Than or Equal to 1.3 | The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful. | A total of 28 patients were enrolled and underwent tumor biopsy for the purposes of this study. 25/28 patients were treated on study with the MMP-selected treatment and were evaluable for the primary end point of GMI. | Posted | Count of Participants | Participants | 6-20 weeks |
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adverse events grade 3 and 4 were collected for 2 years.
The study is a molecular profiling study only. No research intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention Details: Drug: (will be assigned based on molecular profile and RPMA) Basis for decision making: treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results | 0 | 25 | 5 | 25 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hand-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Vocila, Executive Director Clinical Strategy | Translational Drug Development | 6023588311 | lvocila@td2inc.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Unknown |
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