drugset / Trial / NCT01493310
Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer
RandomizedCrossoverDouble-blindTreatment
Summary
This trial will find the best dose of mifepristone when given together with nab-paclitaxel (Abraxane) based on the side effects of the two drugs in patients with advanced breast cancer. Patients will be randomized to receive nab-paclitaxel with or without mifepristone during the first treatment cycle. After the first cycle, all patients will receive nab-paclitaxel with mifepristone until their disease worsens or they experience an unacceptable side effect. This study will test up to 4 doses of mifepristone in combination with nab-paclitaxel. The study will first test the lowest dose in a small group of patients and if they do not have bad side effects, higher doses will be tested.
Timeline
- Start
- 2011-11
- Primary completion
- 2018-05
- Completion
- 2018-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 300 mg | Oral |
| Subject | Mifepristone | Small molecule | 600 mg | Oral |
| Subject | Mifepristone | Small molecule | 900 mg | Oral |
| Subject | Mifepristone | Small molecule | 1200 mg | Oral |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |