Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Enzalutamide; exemestane; Placebo (for enzalutamide); exemestane
Intervention description: 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.; 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.; Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.; 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.
Intervention MeSH terms: Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced breast cancer; enzalutamide; MDV3100; Estrogen receptor positive (ER +); Progesterone receptor positive (PgR +); HER-2 normal

Summary:

      The purpose of this study is to determine if enzalutamide given in combination with
      exemestane is safe and effective in patients with advanced breast cancer.
    

Eligibility criteria:

        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;

          -  Eastern Cooperative Oncology Group (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.