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This clinical trial will evaluate whether treatment with ridaforolimus, dalotuzumab, or ridforolimus/dalotuzumab combination therapy reduces Growth Factor Signature (GFS) Score among participants with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus + Dalotuzumab | Experimental | Ridaforolimus (MK-8669) + Dalotuzumab (MK-0646) |
|
| Ridaforolimus | Experimental | Ridaforolimus (MK-8669) |
|
| Dalotuzumab | Experimental | Dalotuzumab (MK-0646) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridaforolimus + Dalotuzumab | Drug | Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The population mean change from baseline in GFS (Growth Factor Signature) score | Baseline and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| The population mean change from baseline in Ki67 among participants receiving ridaforolimus/dalotuzumab combination therapy | Baseline and Day 15 | |
| The correlation between change in Ki67 expression and change in GFS after two weeks of treatment with ridaforolimus/dalotuzumab (MK-8669/MK-0646) combination therapy, ridaforolimus (MK-8669) monotherapy and/or dalotuzumab (MK-0646) monotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Ridaforolimus | Drug | Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets |
|
|
| Dalotuzumab | Drug | Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks |
|
|
| Baseline and Day 15 |
| 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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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
| C569480 | dalotuzumab |
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