Study on Using Enzalutamide for Early Stage Androgen Receptor Positive Triple Negative Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

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

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

FACILITYZIPCITYSTATE
Hartford Healthcare Cancer Institute @ Hartford Hospital06102HartfordConnecticut
Memorial Sloan Kettering Basking Ridge07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth07748MiddletownNew Jersey
Kings County Hopsital Center11203BrooklynNew York
Coney Island Hospital11235BrooklynNew York
Woodhull HospitalBrooklynNew York
Memorial Sloan Kettering Commack11725CommackNew York
Memorial Sloan Kettering Westchester10604HarrisonNew York
Queens Hospital Center11432JamaicaNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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