Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative 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:
NCT01889238
First received: June 26, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.


Condition Intervention Phase
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Drug: Enzalutamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Single Arm, Open Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor Positive, Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with androgen receptor positive (AR+), triple negative breast cancer (TNBC) with a best response of complete response (CR), partial response (PR), or stable disease (SD) ≥ 16 weeks.


Secondary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: ≥ 24 weeks ] [ Designated as safety issue: No ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with a best response of Complete Response, Partial Response, or Stable Disease ≥ 24 weeks;

  • Best Objective Response Rate [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Ctrough [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide


Other Outcome Measures:
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Androgen Receptor Expression [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
    To determine the extent of androgen receptor (AR) 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.


Estimated Enrollment: 95
Study Start Date: May 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
Drug: Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Other Names:
  • Xtandi®
  • MDV3100

  Eligibility

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

Inclusion Criteria:

  • Women at least 18 years of age;
  • Advanced AR+ TNBC;
  • Availability of a representative tumor specimen:
  • Either measurable disease or bone only nonmeasurable disease;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Any severe concurrent disease, infection, or comorbid condition;
  • 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;
  • Current or previously treated brain metastasis or active leptomeningeal disease;
  • Current hormone replacement therapy;
  • Local palliative radiation therapy within 7 days before day 1;
  • History of another invasive cancer within 5 years of day 1;
  • Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit;
  • Creatinine > 1.5 times ULN at the screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Active gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks before day 1;
  • Treatment with any commercially available anticancer agent within 14 days before day 1;
  • Treatment with any investigational agent within 2 weeks before day 1;
  • Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy;
  • Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
  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: NCT01889238

Contacts
Contact: Jane Dennison 855-349-1891 breastcancertrials@medivation.com

  Hide Study Locations
Locations
United States, Colorado
Recruiting
Lakewood, Colorado, United States, 80228
United States, Florida
Recruiting
Fort Myers, Florida, United States, 33916
Recruiting
St. Petersburg, Florida, United States, 33705
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Recruiting
Morristown, New Jersey, United States, 07962
United States, New York
Recruiting
New York, New York, United States, 10065
United States, North Carolina
Recruiting
Greensboro, North Carolina, United States, 27403
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Recruiting
Memphis, Tennessee, United States, 38119
Recruiting
Nashville, Tennessee, United States, 37203
Recruiting
Nashville, Tennessee, United States, 37204
United States, Texas
Recruiting
Dallas, Texas, United States, 75246
Recruiting
Houston, Texas, United States, 77024
Recruiting
Tyler, Texas, United States, 75702
United States, Virginia
Recruiting
Norfolk, Virginia, United States, 23502
Recruiting
Richmond, Virginia, United States, 23235
Belgium
Recruiting
Edegem, Antwerpen, Belgium, 2650
Recruiting
Wilrijk, Antwerpen, Belgium, 2610
Recruiting
Brussels, Belgium, 1000
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Recruiting
Toronto, Ontario, Canada, M4N3M5
Canada, Quebec
Recruiting
Montreal, Quebec, Canada, H3G1A4
Ireland
Recruiting
Dublin, Ireland
Recruiting
Dublin, Ireland, 9
Recruiting
Galway, Ireland
Recruiting
Limerick, Ireland
Italy
Recruiting
Bologna, Italy, 40138
Recruiting
Milano, Italy, 20132
Recruiting
Milano, Italy, 20141
Recruiting
Perugia, Italy, 06156
Recruiting
Prato, Italy, 59100
Recruiting
Roma, Italy, 0144
Spain
Recruiting
Barcelona, Spain, 08035
Recruiting
Madrid, Spain, 28034
Recruiting
Madrid, Spain, 28041
Recruiting
Madrid, Spain, 28050
United Kingdom
Recruiting
Brighton, United Kingdom, BN25BE
Recruiting
Nottingham, United Kingdom, NG51PB
Recruiting
Truro, United Kingdom, TR13LJ
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Chair: Amy Peterson, MD Medivation, Inc.
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01889238     History of Changes
Other Study ID Numbers: MDV3100-11, 2013 000698 57
Study First Received: June 26, 2013
Last Updated: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
breast cancer
triple negative
androgen receptor positive

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014