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A Randomized Phase I Trial of Nanoparticle Albumin Bound Paclitaxel (Nab-paclitaxel, Abraxane) With or Without Mifepristone for Advanced Breast Cancer
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.
Details
| Lead sponsor | University of Chicago |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 9 |
| Start date | 2011-11 |
| Completion | 2018-05 |
Conditions
- Male Breast Cancer
- Recurrent Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Stage IV Breast Cancer
Interventions
- mifepristone
- placebo
- nab-paclitaxel
Primary outcomes
- Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel — 28days (Cycle 1)
This study will seek the safest dose of mifepristone given in combination with nab-paclitaxel. Safety of each dose will be determined by the number and seriousness of side effects experienced by patients receiving each dose.
Countries
United States