Enzalutamide in Combination with Exemestane in Advanced Breast Cancer
Research type
Research Study
Full title
A Phase 2, Randomized, Double Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 Normal
IRAS ID
137610
Contact name
Peter Schmid
Contact email
Sponsor organisation
Medivation, Inc.
Eudract number
2013-002717-35
Research summary
This phase 2 study is designed to evaluate the tolerability and activity of adding enzalutamide to exemestane treatment in women with advanced breast cancer that is oestrogen or progesterone receptor-positive or both (ER+/PgR+) and human epidermal growth factor receptor 2 (HER2)-normal. This study will also evaluate whether the activity of enzalutamide is restricted to patients with androgen receptor-positive (AR+) disease.
The purpose is to determine whether enzalutamide and exemestane, taken together are better at slowing the growth of breast cancer than exemestane alone. This study is also being done to test whether these 2 study medications can be given together safely to women with their type of breast cancer.
Enzalutamide is approved by the European Medicines Agency as treatment for men with prostate. The use of enzalutamide in this study is experimental. Enzalutamide received a positive opinion in 2013 from CHMP (The Committee for Medicinal Products for Human Use). Exemestane has already been approved for the treatment of breast cancer.
Eligible patients will take 4 capsules (160 mg) of enzalutamide and 1 capsule (50 mg) of exemestane by mouth once daily. If the patient is assigned to placebo and exemestane, she will take 4 capsules of placebo and 1 capsule (25 mg) of exemestane by mouth once daily. The dose of exemestane is different for the 2 treatment groups because enzalutamide decreases the body’s ability to take up exemestane by about one half. To make sure that both groups of patients are getting similar amounts of exemestane, patients assigned to take enzalutamide will need to take double the dose of exemestane (50 mg daily).
The double-blind treatment period ends when study tests show that the patient`s cancer has “progressed”, or got worse. The patient`s participation for Open-Label treatment depends on whether or not the cancer has got worse.
About 240 patients will be enrolled into this study across approximately 50 study centres in North America and Europe.REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1720
Date of REC Opinion
15 Feb 2014
REC opinion
Further Information Favourable Opinion