Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xtandi®
Product Name: Enzalutamide
Pharmaceutical Form: Capsule
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Sponsors
Medivation, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Advanced AR+ (any nuclear AR staining by IHC) TNBC, where advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent; • Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer; • Either measurable disease or bone-only nonmeasurable disease; • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Current or previously treated brain metastasis or active leptomeningeal disease; head imaging is required during screening; • Current hormone replacement therapy; • Abnormal hematology, liver function tests and creatinine laboratory values at screening; • History of seizure or any condition that may predispose to seizure; • History of loss of consciousness or transient ischemic attack within past 12 months; • An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease; uncontrolled celiac disease); • Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700); patients who received treatment for < 28 days or placebo on an investigational study are acceptable; • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine clinical benefit rate in patients with AR+ triple-negative breast cancer (TNBC).; Secondary Objective: To determine additional measures of clinical benefit including response rate, duration of response and PFS To assess the safety, tolerability and PK of enzalutamide and its active metabolite ;Primary end point(s): Clinical benefit rate, defined as the proportion of evaluable patients with a best response of CR, PR, or SD > 16 weeks;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Additional measures include clinical benefit at >24 weeks, best objective response rate, duration of response and PFS, will be evaluated;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression | — |
Countries
Belgium, Canada, Ireland, Italy, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Medivation, Inc.
Outcome results
None listed