Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Chicago
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have metastatic (stage IV) or unresectable (cannot be removed by surgery) stage III breast cancer
Patients must have evaluable disease
Patients may have received adjuvant chemotherapy and up to four prior chemotherapy regimens for metastatic or locally recurrent disease and cannot have received prior nab-paclitaxel or mifepristone therapy for metastatic disease
Patients who are estrogen receptor (ER)- and/or progesterone receptor (PR)-positive must have developed metastatic disease while on adjuvant hormonal therapy or have progression of disease after at least one hormonal therapy for advanced disease) and may have received unlimited prior hormonal therapies
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \> 60%)
Absolute neutrophil count \>= 1,500/mL
Platelets \>= 100,000/mL
Total bilirubin =\< institutional upper limit of normal (ULN)
Creatinine =\< institutional ULN OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
Morning cortisol \>= institutional normal
Negative serum or urine pregnancy test is required for women of child-bearing potential (able to get pregnant)
Women of child-bearing potential and men who are sexually active must agree to use two forms of birth control prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document
You may not be if
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Patients may not be receiving any other investigational drugs or treatments
Patients with known brain metastases are eligible as long as they have completed radiation to the brain and have been off of corticosteroid therapy for at least 4 weeks
History of allergic reactions to compounds similar to mifepristone or paclitaxel/nab-paclitaxel; patients with a history of mild infusion reactions with paclitaxel who were able to continue to receive paclitaxel with corticosteroid premedications will be eligible to participate, as these cases were likely related to Cremophor and not paclitaxel
Mifepristone may affect the way the body processes some types of drugs so they cannot be taken while on-study. These include but are not limited to non-steroidal anti-inflammatory drugs (NSAIDs) or warfarin, cyclosporine, certain benzodiazepines. The study doctor will review patient's current medications to determined if any are prohibited from the study.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if patient wishes to participate in the study
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
No history of long-term or ongoing short term use of corticosteroids is allowed
Clareo Health | Nab-paclitaxel (Abraxane) With or Without Mifepristone in Patients With Advanced Breast Cancer
