drugset / Trial / NCT01939418
Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study consists of two parts. In a phase Ib part, investigators will explore the recommended dose of gemcitabine, cisplatin, and RAD001 combination in patients with metastatic TNBC. After completing the phase Ib part, investigators will review the data and discuss with Novartis before the start of a phase II part. In the phase II part, investigators will compare the efficacy of the gemcitabine and cisplatin with or without RAD001 in patients with metastatic TNBC.
Timeline
- Start
- 2013-08
- Primary completion
- 2016-07-30
- Completion
- 2017-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Everolimus | Small molecule | 5 mg | Oral |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |