Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medivation, Inc.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT02007512
First received: December 3, 2013
Last updated: July 28, 2014
Last verified: July 2014

December 3, 2013
July 28, 2014
November 2013
September 2016   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
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 or progesterone receptor-positive or both (ER+/PgR+) and human epidermal growth factor receptor 2 (HER2)-normal
Same as current
Complete list of historical versions of study NCT02007512 on ClinicalTrials.gov Archive Site
  • Clinical Benefit Rate [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    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.
  • Pharmacokinetics [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Cmax for enzalutamide and exemestane one hour pre dose and exemestane 6 hours post dose at specified study visits.
Same as current
  • Health-related Quality of Life [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Assessments of health-related quality of life will be performed using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life core questionnaire (QLQ-C30) and breast cancer module(QLQ-BR23) at specified intervals and at time of disease progression.
  • Androgen Receptor (AR) Expression by Immunohistochemistry (IHC) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    To determine the percent of androgen receptor (AR) nuclear expression and signaling in breast tissue and to evaluate the relationship of this expression with enzalutamide effects on circulating tumor biomarkers, circulating hormones, and clinical outcomes.
Same as current
 
Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
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

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.

This is 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Enzalutamide
    160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food.
    Other Names:
    • MDV3100
    • XTANDI
  • Drug: exemestane
    25 mg or 50 mg tablet administered as a single capsule by mouth once daily after food.
  • Drug: Placebo (for enzalutamide)
    Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
  • Experimental: Enzalutamide & exemestane
    Enzalutamide 160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg tablet once daily after food.
    Interventions:
    • Drug: Enzalutamide
    • Drug: exemestane
  • Active Comparator: placebo & exemestane
    placebo and exemestane 25 mg once daily after food.
    Interventions:
    • Drug: exemestane
    • Drug: Placebo (for enzalutamide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
March 2017
September 2016   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Jane Dennison 855-349-1891 breastcancertrials@medivation.com
Contact: Amy Grekowicz, MPH (415) 543-3470 mdv3100_12@medivation.com
United States,   Belgium,   Italy,   Spain
 
NCT02007512
MDV3100-12
No
Medivation, Inc.
Medivation, Inc.
Astellas Pharma Inc
Not Provided
Medivation, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP