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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Given orally (by mouth) Up to 4 doses of mifepristone will be studied (300 mg, 600 mg, 900 mg, 1200 mg)
Given orally
Given by intravenous infusion (IV) Dose of 80 mg/m2
University of Chicago
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Determination of the safest dose of mifepristone when given in combination with nab-paclitaxel
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.
Time frame: 28days (Cycle 1)
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