NCT02750358

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started May 2016

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

May 19, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

April 21, 2016

Last Update Submit

June 19, 2025

Conditions

Breast CancerEarly StageTriple Negative Breast Cancer

Keywords

Enzalutamide15-307

Outcome Measures

Primary Outcomes (1)

  • The treatment discontinuation rate of enzalutamide in the adherent population

    feasibility

    3 years

Study Arms (1)

Enzalutamide

EXPERIMENTAL

160mg orally as daily continuous dosing for 52 weeks. Patients will be seen for protocol visits every 4 weeks (+/- 2 week window) for the first 12 weeks followed by every 12 weeks (+/- 2 week window) to complete 52 weeks. An assessment will also be performed at 52 weeks (+ 4 week window).

Drug: EnzalutamideBehavioral: assessment

Interventions

EnzalutamideDRUG
Enzalutamide
assessmentBEHAVIORAL
Also known as: Functional Assessment of Cancer Therapy-Breast (FACT-B) scale
Enzalutamide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • +1 more criteria

You may not qualify if:

  • Any severe concurrent disease, infection or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or interferes with the patient's ability to participate in the study requirements.
  • Evidence of metastatic/Stage 4 breast cancer
  • History of another invasive cancer within 5 years with the exceptions of nonmelanoma skin cancers and AJCC Stage 0 or 1 cancers that have a remote probability of recurrence in the opinion of the investigator
  • Absolute neutrophil count \< 1500/μL, platelet count \< 75,000/μL, or hemoglobin \< 9 g/dL (5.6 mmol/L).
  • Total bilirubin \> 1.5 times upper limit of normal (ULN) unless an alternate nonmalignant etiology exists (eg, Gilbert's disease). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times ULN.
  • Creatinine \> 1.5 times ULN or an estimated creatinine clearance \< 50 mL/minute calculated using the Cockcroft-Gault equation.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months before day 1
  • An active gastrointestinal disorder affecting absorption (eg, gastrectomy, active peptic ulcer disease, uncontrolled celiac)
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Kings County Hopsital Center

Brooklyn, New York, 11203, United States

Location

Coney Island Hospital

Brooklyn, New York, 11235, United States

Location

Woodhull Hospital

Brooklyn, New York, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Queens Hospital Center

Jamaica, New York, 11432, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

enzalutamideRestraint, PhysicalWeights and Measures

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Tiffany Traina, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

April 25, 2016

Study Start

May 19, 2016

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations

US(12)