Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
NCT ID: NCT01889238
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2013-06-12
2024-01-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Interventions
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Enzalutamide
160 mg administered as four soft gelatin capsules orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Pfizer CT.gov Call Center
Role: STUDY_CHAIR
Pfizer
Locations
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Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Rocky Mountain Cancer Center Sky Ridge
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Florida Cancer Specialists
Altamonte Springs, Florida, United States
Florida Cancer Specialists
Bonita Springs, Florida, United States
Florida Cancer Specialists
Bradenton, Florida, United States
Florida Cancer Specialists
Brandon, Florida, United States
Florida Cancer Specialists
Cape Coral, Florida, United States
Florida Cancer Specialists
Clearwater, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialist South Division
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
Gainesville, Florida, United States
Florida Cancer Specialists
Hudson, Florida, United States
Florida Cancer Specialists
Largo, Florida, United States
Florida Cancer Specialists
Naples, Florida, United States
Florida Cancer Specialists
New Port Richey, Florida, United States
Florida Cancer Specialists
Orange City, Florida, United States
Florida Cancer Specialists
Orlando, Florida, United States
Florida Cancer Specialists
Port Charlotte, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Florida Cancer Specialists
Spring Hill, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
Tampa, Florida, United States
Florida Cancer Specialists
Tavares, Florida, United States
Florida Cancer Specialists
Venice, Florida, United States
Florida Cancer Specialists
Venice, Florida, United States
Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories
Chicago, Illinois, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Investigational Drug Services
Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Springmill Medical Clinic
Indianapolis, Indiana, United States
Oncology Hematology Care, Inc.
Crestview Hills, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The West Clinic, PC
Corinth, Mississippi, United States
The West Clinic, PC
Southaven, Mississippi, United States
Siteman Cancer Center
City of Saint Peters, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center-West County
St Louis, Missouri, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States
Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Wesley Long Community Hospital
Greensboro, North Carolina, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States
Oncology Hematology Care, Inc.
Fairfield, Ohio, United States
Greenville Health System
Greenville, South Carolina, United States
Greenville Health System
Seneca, South Carolina, United States
Greenville Health System
Spartanburg, South Carolina, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States
The West Clinic, PC
Memphis, Tennessee, United States
The West Clinic, PC
Memphis, Tennessee, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
Vanderbilt Health Pharmacy One Hundred Oaks
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Texas Oncology - Longview Cancer Center
Longview, Texas, United States
Texas Oncology-Tyler
Tyler, Texas, United States
Virginia Cancer Institute
Mechanicsville, Virginia, United States
Virginia Cancer Institute
Midlothian, Virginia, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Virginia Oncology Associates
Virginia Beach, Virginia, United States
UZA
Edegem, Antwerpen, Belgium
Institut Jules Bordet
Brussels, , Belgium
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada
Department of Radiology
Dooradoyle, Limerick, Ireland
3rd Floor,Oncology Link office
Dublin, , Ireland
Department of Radiology
Dublin, , Ireland
Institute for Cancer Research
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Pharmacy Department
Dublin, , Ireland
Radiology Department
Dublin, , Ireland
Pharmacy Department
Dublin, , Ireland
Cancer Clinical Trials Unit, Mid-Western Cancer center
Limerick, , Ireland
Pharmacy Department
Limerick, , Ireland
Dipartimento di Oncologia Medica, IRCCS Ospedale San Raffaele
Milan, , Italy
Farmacia (magazzino ricevimento merc), IRCCS Ospedale San Raffaele
Milan, , Italy
U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi
Prato, , Italy
U.O. Oncologia Medica, Nuovo Ospedale di Prato
Prato, , Italy
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Grupo Hospitalario Quiron - Hospital Quiron Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 Octubre
Madrid, , Spain
Centro Intergral Oncologico Clara Campal
Madrid, , Spain
Hospital de Madrid Norte-Sanchinarro.
Madrid, , Spain
Clinical Investigation and Research Unit
Brighton, England, United Kingdom
Pharmacy Department
Brighton, England, United Kingdom
Radiation Safety Service, Medical Physics Department
Brighton, England, United Kingdom
Histopathology Department
Nottingham, England, United Kingdom
Nottingham University Hospital
Nottingham, England, United Kingdom
Pharmacy Department
Nottingham, England, United Kingdom
Radiology Department
Nottingham, England, United Kingdom
Radiology Department
Nottingham, England, United Kingdom
Department of Radiology
Truro, England, United Kingdom
Pharmacy Department
Truro, England, United Kingdom
Royal Cornwall Hospitals NHS trust
Truro, Cornwall, England, United Kingdom
Countries
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References
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Kumar V, Yu J, Phan V, Tudor IC, Peterson A, Uppal H. Androgen Receptor Immunohistochemistry as a Companion Diagnostic Approach to Predict Clinical Response to Enzalutamide in Triple-Negative Breast Cancer. JCO Precis Oncol. 2017 Nov;1:1-19. doi: 10.1200/PO.17.00075.
Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26.
Other Identifiers
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2013-000698-57
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3431007
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-11
Identifier Type: -
Identifier Source: org_study_id