Breast Cancer, Early Stage, Triple Negative Breast Cancer
Conditions
Keywords
Enzalutamide, 15-307
Brief summary
This trial is designed to determine the feasibility of 1 year of adjuvant enzalutamide, an androgen receptor (AR) antagonist for the treatment of patients with early stage, AR(+) triple negative breast cancer (TNBC).
Interventions
DRUGEnzalutamide
BEHAVIORALassessment
Sponsors
Memorial Sloan Kettering Cancer Center
Medivation, Inc.
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The study population for Step 1 must meet the following eligibility criteria: Inclusion Criteria: * Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER \<1, PR \<1 and HER2 0 or 1+ or FISH not amplified if IHC 2+. * AR testing may be performed while patient is undergoing other adjuvant therapy (i.e., surgery, chemotherapy, radiation). * Willing and able to provide informed consent. Woman at least 18 years of age. * Patient is a candidate for treatment of their early stage breast cancer. The study population for Step 2 will meet the eligibility criteria: Inclusion Criteria: * Stage 1, 2 or 3 invasive breast cancer which is triple negative. Triple negative breast cancer is defined as ER \<1%, PR \<1% and HER2 0 or 1+ or FISH not amplified if IHC 2+. * AR(+), defined as ≥1% nuclear staining by IHC testing. The assessment of AR expression may have been performed any time in the past and is not limited to participation in Step 1. * Any neoadjuvant or adjuvant chemotherapy regimen is permitted. Prior chemotherapy for the treatment of this breast cancer is not required. * At least 4 weeks from end of surgery, chemotherapy, or radiotherapy with resolution of any toxicity to Grade 1 or less, excluding alopecia. * Patients are eligible to participate within 6 months of completion of therapy for their breast cancer. This includes prior radiation therapy if needed. * ECOG performance status of 0 or 1. * Willing and able to provide informed consent. * Woman at least 18 years of age. * Able to swallow study drug and comply with study requirements. * Women of childbearing potential must have a negative pregnancy test and must agree to use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. * Is not breastfeeding at screening and will not breastfeed throughout the study period and for at least 3 months after final drug administration.
Exclusion criteria
Each patient eligible to participate in this study must NOT meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The treatment discontinuation rate of enzalutamide in the adherent population | 3 years | feasibility |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTiffany Traina, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed