Study on Abraxane® With or Without Mifepristone for Advanced Triple-Negative Breast Cancer
Sponsor: University of Chicago
ClinicalTrials ID:NCT02788981
This clinical trial is testing whether adding the drug mifepristone to the standard treatment with Abraxane® can improve outcomes for patients with advanced triple-negative breast cancer that is positive for glucocorticoid receptors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the effects of combining Abraxane® (nab-paclitaxel) with or without mifepristone in patients with advanced triple-negative breast cancer that has a specific receptor called glucocorticoid receptor. The trial involves 64 patients who will receive Abraxane® and be randomly assigned to also receive either mifepristone or a placebo. The study will last for about two years, including a year of treatment and a year of follow-up. Researchers will also study how these drugs interact in the first 20 patients at specific sites.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with Abraxane® plus a placebo versus Abraxane® plus mifepristone. Researchers will also look at how the presence of glucocorticoid receptors in the cancer affects outcomes, the overall response rate to the treatments, and collect data on overall survival.
Participants must have advanced breast cancer that cannot be removed by surgery and must have measurable tumors. The cancer must be triple-negative, meaning it does not have certain hormone receptors, and must be positive for glucocorticoid receptors. Participants can have had some previous treatments but not with Abraxane® or mifepristone for their advanced cancer. They must be adults in good health with normal organ function and agree to use contraception if they are of childbearing potential.
Eligibility Criteria
Inclusion Criteria
- Have advanced breast cancer that cannot be surgically removed.
- Have measurable tumors that can be tracked using scans or exams.
- Have triple-negative breast cancer, meaning it lacks certain hormone receptors.
- Have cancer that is positive for glucocorticoid receptors.
- Have not received Abraxane® or mifepristone for advanced cancer.
- Be 18 years or older.
- Be in good overall health with normal organ and marrow function.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must use a condom during sexual contact with women of childbearing potential.
- Have no more than mild pre-existing nerve damage.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Currently receiving other investigational treatments.
- Have had recent chemotherapy or radiation therapy.
- Have another active cancer, except for certain skin cancers.
- Have known brain metastases unless treated and stable.
- Have allergies to similar drugs as mifepristone or Abraxane®.
- Taking medications that interact with mifepristone.
- Have uncontrolled illnesses or infections.
- Pregnant or breastfeeding women.
- HIV-positive patients on antiretroviral therapy.
- Have a history of long-term corticosteroid use.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama - Birmingham | 35924 | Birmingham | Alabama |
| University of Chicago | 60637 | Chicago | Illinois |
| Northshore University HealthSystem | 60201 | Evanston | Illinois |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| Froedtert and the Medical College of Wisconsin | 53226 | Milwaukee | Wisconsin |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.