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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02007512
First received: December 3, 2013
Last updated: July 31, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Breast Cancer Drug: Enzalutamide Drug: exemestane Drug: Placebo (for enzalutamide) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 24 Months ]
    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


Secondary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: 24 Months ]

    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 ]
    Cmax for enzalutamide and exemestane one hour pre dose and exemestane 6 hours post dose at specified study visits.


Other Outcome Measures:
  • Health-related Quality of Life [ Time Frame: 24 Months ]
    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 ]
    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.


Enrollment: 247
Actual Study Start Date: December 20, 2013
Estimated Study Completion Date: June 29, 2018
Primary Completion Date: September 23, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 capsule once daily after food.
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
50 mg capsule administered as a single capsule by mouth once daily after food.
Active Comparator: placebo & exemestane
placebo and exemestane 25 mg once daily after food.
Drug: exemestane
25 mg capsule 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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02007512

  Show 173 Study Locations
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Director: Medical Director Medivation, Inc.
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02007512     History of Changes
Other Study ID Numbers: MDV3100-12
2013-002717-35 ( EudraCT Number )
C3431008 ( Other Identifier: Alias Study Number )
Study First Received: December 3, 2013
Last Updated: July 31, 2017

Keywords provided by Pfizer:
advanced breast cancer
enzalutamide
MDV3100
Estrogen receptor positive (ER +)
Progesterone receptor positive (PgR +)
HER-2 normal

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Progesterone
Estrogens
Exemestane
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on August 23, 2017