Breast Cancer MedDRA version: 17.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Medivation, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Advanced, histologically confirmed breast cancer (primary tumor) that is ER+ and/or PgR+, and HER2-normal • Cohort 1: patients who have not previously received hormone treatment for advanced breast cancer and the subset that is also AR+ • Cohort 2: patients who previously progressed following 1 hormone treatment for advanced breast cancer and the subset that is also AR+ • Up to one prior chemotherapy regimen for advanced disease is allowed for either Cohort • Non-measurable bone and skin disease is allowed • Patients must be post-menopausal • Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer; • 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Current or previously treated brain metasis or active leptomeningeal disease; • Abnormal hematology, liver function tests or 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 12 months before randomization; • An active gastrointestinal disorder affecting absorption (eg, gastrectomy, uncontrolled celiac disease); • Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (eg, 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.); • Prior therapy (> 28 days) with exemestane in the metastatic setting. (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible.); • 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: To determine the benefit of exemestane plus enzalutamide versus exemestane plus placebo as assessed by progression free survival (PFS) in patients with advanced breast cancer that is estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) normal and in the subset of patients whose breast cancer also expresses the androgen receptor. ;Secondary Objective: To determine additional measures of clinical benefit including clinical benefit rate, response rate, duration of response, time to response, time to progression and PFS at 6 months. To assess the safety, tolerability of exemestane plus enzalutamide versus exemestane plus placebo. To assess the PK of exemestane and of enzalutamide and its active metabolites. ;Primary end point(s): Progression-free survival ;Timepoint(s) of evaluation of this end point: Time from randomisation to disease progression; for those patients who discontinue from study drug treatment without documented progression, tumor assessment will continue until disease progression occurs (until death, withdrawal of consent, initiation of alternate anticancer therapy, or lost-to-follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To determine the benefit of exemestane plus enzalutamide versus exemestane plus placebo in each cohort and in the subset that is also AR+ assessed as follows: - Clinical benefit rate, defined as the proportion of patients with a best response of complete response (CR), partial response (PR), or of stable disease (SD) lasting = 24 weeks; - Best objective response rate; - Duration of response; - Time to response; - Time to progression; - PFS rate at 6 months. • To assess the pharmacokinetics (PK) of exemestane, enzalutamide, and the active metabolite N-desmethyl enzalutamide; • To assess safety and tolerability. ;Timepoint(s) of evaluation of this end point: Time from randomisation 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