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Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative 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:
NCT01889238
First received: June 26, 2013
Last updated: August 2, 2017
Last verified: August 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 Pfizer:

Primary Outcome Measures:
  • Clinical Benefit Rate [ Time Frame: ≥ 16 weeks ]
    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 ]
    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 ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ]
  • Time to Response [ Time Frame: ≥ 16 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ]
  • Pharmacokinetics - Ctrough (predose plasma concentration) [ Time Frame: ≥ 16 weeks ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide


Other Outcome Measures:
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ]
  • Androgen Receptor Expression [ Time Frame: ≥ 16 weeks ]
    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.


Enrollment: 118
Actual Study Start Date: June 12, 2013
Estimated Study Completion Date: December 31, 2017
Primary Completion Date: March 1, 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   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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 upper limit of normal (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

  Hide Study Locations
Locations
United States, Colorado
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124
United States, Florida
Florida Cancer Specialists
Altamonte Springs, Florida, United States, 32701
Florida Cancer Specialists
Bonita Springs, Florida, United States, 34135
Florida Cancer Specialists
Bradenton, Florida, United States, 34209
Florida Cancer Specialists
Brandon, Florida, United States, 33511
Florida Cancer Specialists
Cape Coral, Florida, United States, 33914
Florida Cancer Specialists
Clearwater, Florida, United States, 33761
Florida Cancer Specialists
Fort Myers, Florida, United States, 33905
Florida Cancer Specialists
Fort Myers, Florida, United States, 33908
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
Florida Cancer Specialists
Gainesville, Florida, United States, 32605
Florida Cancer Specialists
Hudson, Florida, United States, 34667
Florida Cancer Specialists
Largo, Florida, United States, 33770
Florida Cancer Specialists
Naples, Florida, United States, 34102
Florida Cancer Specialists
New Port Richey, Florida, United States, 34655
Florida Cancer Specialists
Orange City, Florida, United States, 32763
Florida Cancer Specialists
Orlando, Florida, United States, 32806
Florida Cancer Specialists
Port Charlotte, Florida, United States, 33980
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Florida Cancer Specialists
Sarasota, Florida, United States, 34236
Florida Cancer Specialists
Spring Hill, Florida, United States, 34608
Florida Cancer Specialists
Tampa, Florida, United States, 33607
Florida Cancer Specialists
Tavares, Florida, United States, 32778
Florida Cancer Specialists
Venice, Florida, United States, 34285
Florida Cancer Specialists
Venice, Florida, United States, 34292
United States, Illinois
Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories
Chicago, Illinois, United States, 60611
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy
Chicago, Illinois, United States, 60637
The University of Chicago
Chicago, Illinois, United States, 60637
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States, 60451
United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Investigational Drug Services
Indianapolis, Indiana, United States, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Springmill Medical Clinic
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Oncology Hematology Care, Inc.
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Mississippi
The West Clinic, PC
Corinth, Mississippi, United States, 38834
The West Clinic, PC
Southaven, Mississippi, United States, 38671
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Washington University Infusion Center Pharmacy
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-South County
Saint Louis, Missouri, United States, 63129
Siteman Cancer Center-West County
Saint Louis, Missouri, United States, 63141
Siteman Cancer Center
Saint Peters, Missouri, United States, 63376
United States, New Jersey
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07962
United States, New York
Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service
New York, New York, United States, 10065
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45211
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45219
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Oncology Hematology Care, Inc.
Fairfield, Ohio, United States, 45014
United States, South Carolina
Greenville Health System
Greenville, South Carolina, United States, 29605
Greenville Health System
Seneca, South Carolina, United States, 29672
Greenville Health System
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37087
The West Clinic, PC
Memphis, Tennessee, United States, 38104
The West Clinic, PC
Memphis, Tennessee, United States, 38120
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37129
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States, 37204
Vanderbilt Health Pharmacy One Hundred Oaks
Nashville, Tennessee, United States, 37204
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Longview Cancer Center
Longview, Texas, United States, 75601
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Institute
Mechanicsville, Virginia, United States, 23116-1844
Virginia Cancer Institute
Midlothian, Virginia, United States, 23114
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Virginia Cancer Institute
Richmond, Virginia, United States, 23235-4730
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada, H4A 3J1
Ireland
Pharmacy Department
Dublin 4, Ireland
3rd Floor,Oncology Link office
Dublin, Ireland, 4
Department of Radiology
Dublin, Ireland, 4
Institute for Cancer Research
Dublin, Ireland, 7
Mater Private Hospital
Dublin, Ireland, 7
Pharmacy Department
Dublin, Ireland, 7
Radiology Department
Dublin, Ireland, 7
Italy
U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi
Prato, Italy, 59100
Spain
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain, 28660
Grupo Hospitalario Quiron - Hospital Quiron Barcelona
Barcelona, Spain, 08023
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Hospital Universitario 12 Octubre
Madrid, Spain, 28041
Centro Intergral Oncologico Clara Campal
Madrid, Spain, 28050
Hospital de Madrid Norte-Sanchinarro.
Madrid, Spain, 28050
United Kingdom
Clinical Investigation and Research Unit
Brighton, England, United Kingdom, BN2 5BE
Pharmacy Department
Brighton, England, United Kingdom, BN2 5BE
Radiation Safety Service, Medical Physics Department
Brighton, England, United Kingdom, BN2 5BE
Histopathology Department
Nottingham, England, United Kingdom, NG5 1PB
Nottingham University Hospital
Nottingham, England, United Kingdom, NG5 1PB
Pharmacy Department
Nottingham, England, United Kingdom, NG5 1PB
Radiology Department
Nottingham, England, United Kingdom, NG7 2UH
Royal Cornwall Hospitals NHS trust
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Department of Radiology
Truro, England, United Kingdom, TR1 3LJ
Pharmacy Department
Truro, England, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
Study Chair: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01889238     History of Changes
Other Study ID Numbers: MDV3100-11
2013-000698-57 ( EudraCT Number )
C3431007 ( Other Identifier: Alias Study Number )
Study First Received: June 26, 2013
Last Updated: August 2, 2017

Keywords provided by Pfizer:
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

ClinicalTrials.gov processed this record on August 18, 2017