Study on Using Enzalutamide for Early Stage Androgen Receptor Positive Triple Negative Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT02750358
This clinical trial is exploring the possibility of using enzalutamide, a medication that blocks certain receptors, for one year as an additional treatment for patients with early stage androgen receptor positive (AR+) triple negative breast cancer.
Patient Parameters
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Program Overview
The aim of this study is to see if it is feasible to use enzalutamide, a drug that blocks androgen receptors, as an additional treatment for patients with early stage triple negative breast cancer that tests positive for androgen receptors (AR+). The study will involve patients who have completed their initial treatments like surgery, chemotherapy, or radiation.
Eligibility Criteria
Inclusion Criteria
- Have stage 1, 2, or 3 invasive breast cancer that is triple negative, meaning it does not have certain hormone receptors.
- Have cancer that tests positive for androgen receptors (AR+).
- Have completed surgery, chemotherapy, or radiation at least 4 weeks ago, with any side effects reduced to mild levels.
- Be within 6 months of finishing initial breast cancer treatment.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Be a woman aged 18 or older.
- Be able to swallow the study medication and follow study requirements.
- Women who can become pregnant must have a negative pregnancy test and agree to use two forms of birth control during the study and for 3 months after.
- Not be breastfeeding during the study and for at least 3 months after the last dose of the study drug.
Exclusion Criteria
- Have any serious health conditions or infections that would make participating in the study unsafe.
- Have stage 4 breast cancer or cancer that has spread to other parts of the body.
- Have had another invasive cancer in the past 5 years, except for certain skin cancers or very early-stage cancers.
- Have low blood cell counts or low hemoglobin levels.
- Have high levels of certain liver enzymes or bilirubin unless due to a non-cancerous condition.
- Have poor kidney function.
- Have a history of seizures or conditions that increase the risk of seizures.
- Have digestive issues that affect absorption of medication.
- Have allergies to the study drug or its ingredients.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital | 06102 | Hartford | Connecticut |
| Memorial Sloan Kettering Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Kings County Hopsital Center | 11203 | Brooklyn | New York |
| Coney Island Hospital | 11235 | Brooklyn | New York |
| Woodhull Hospital | Brooklyn | New York | |
| Memorial Sloan Kettering Commack | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Queens Hospital Center | 11432 | Jamaica | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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