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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001595-20 | EudraCT Number |
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This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAD001 Daily Schedule | Experimental | 5mg or 10mg |
|
| RAD001 Weekly Schedule | Experimental | 30mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus (RAD001) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To establish the feasible dose levels/regimens based on End-of-cycle-1 dose limiting toxicity (DLT) | after ever DLT within the first cycle, at least 21 days on treatment, every 2 months from first date of enrollment in a particular regimen |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the ability to deliver the trastuzumab and vinorelbine therapy | After LPLV | |
| To assess everolimus, trastuzumab and vinorelbine blood levels in this combination | After LPLV | |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmaceuticals | Novartis Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Brussels | 1000 | Belgium | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21107682 | Derived | Jerusalem G, Fasolo A, Dieras V, Cardoso F, Bergh J, Vittori L, Zhang Y, Massacesi C, Sahmoud T, Gianni L. Phase I trial of oral mTOR inhibitor everolimus in combination with trastuzumab and vinorelbine in pre-treated patients with HER2-overexpressing metastatic breast cancer. Breast Cancer Res Treat. 2011 Jan;125(2):447-55. doi: 10.1007/s10549-010-1260-x. Epub 2010 Nov 25. |
| Label | URL |
|---|---|
| Results for CRAD001J2102 can be found on the Novartis Clinical Trial Results Website | View source |
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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 |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| To evaluate the overall tumor response |
| every 9 weeks/minus 1 week |
| Liège |
| 4000 |
| Belgium |
| Novartis Investigative Site | Paris | 75231 | France |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Warsaw | 02-781 | Poland |
| Novartis Investigative Site | Stockholm | SE-171 76 | Sweden |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |