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Clinical Trial VICCBRE1385


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

Principal Investigator(s)

Vandana Abramson


  • Protocol No. VICCBRE1385
  • Open Date: 03/03/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To determine the benefit of exemestane plus enzalutamide versus exemestane plus placebo as assessed by progreesion-free survival (PFS) in patients with advanced breast cancer that is estrogen or progesterone receptor-positive or both (ER+/PgR+) and human epidermal growth factor receptor 2 (HER2)-normal as follows: Cohort 1: patients who have not previously received hormone treatment for advanced breast cancer and the subset that is also androgen receptor-positive (AR+); Cohort 2: patients who previously progressed following 1 hormone treatment for advanced breast cancer and the subset that is also AR+.
  • Disease Sites: Breast
  • Therapies: Hormonal Therapy
  • Drugs: Enzalutamide; Exemestane; MDV3100
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02007512
  • Secondary Protocol No: MDV3100-12


Enzalutamide is being developed by Medivation, Inc. (Medivation), the sponsor of this study, in partnership with Astellas Pharma, Inc. Enzalutamide blocks the action of androgens on the androgen receptor. Most women with hormone receptor positive breast cancer (about 7 out of 10) also have androgen receptor positive breast cancer (in other words, the same breast cancer cell can express both types of receptors). Enzalutamide could inhibit androgen receptor activity resulting from the increase in androgens from exemestane treatment. Enzalutamide added to exemestane may possibly help to further slow or stop breast tumor growth. The study will help doctors determine if 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 drugs can be given together safely to women with this type of breast cancer.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Willing and able to provide informed consent;
• Postmenopausal;
• Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal;
• Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;
• Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;
• Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;
• ECOG status of 0 or 1;
Exclusion Criteria:
• Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
• Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;
• Current or previously treated brain metastasis or leptomeningeal disease;
• 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);
• Requires treatment for tuberculosis or HIV infection;
• Radiation therapy within 7 days before randomization;
• History of another invasive cancer within 5 years before randomization;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Active gastrointestinal disorder;
• Major surgery within 28 days prior to randomization;
• Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;
• Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;
• Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;
• Hypersensitivity reaction to exemestane.