Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
NCT ID: NCT02007512
Last Updated: 2025-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
247 participants
INTERVENTIONAL
2013-12-16
2024-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enzalutamide & exemestane
Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food.
Enzalutamide
160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.
exemestane
50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.
Placebo & exemestane
Placebo and exemestane 25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet without placebo after unblinding) once daily after food.
exemestane
25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.
Placebo (for enzalutamide)
Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
Interventions
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Enzalutamide
160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.
exemestane
25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.
Placebo (for enzalutamide)
Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
exemestane
50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation, 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
Locations
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ATTN-Research Pharmacist
Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
University of Colorado Hospital, Anschutz Outpatient Pavilion
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers
Lakewood, 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
Englewood, Florida, United States
Florida Cancer Specialists
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
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medical Center,
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
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Minnesota Oncology Hematology, P.A
Minneapolis, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Allina Health System DBA Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Dr.Michaela Tsai
Minneapolis, Minnesota, United States
The West Clinic, P.C.
Corinth, Mississippi, United States
The West Clinic, P.C. d/b/a West Cancer Center
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 Cancer Center
New York, New York, 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
Franklin, Tennessee, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States
The West Clinic, P.C. d/b/a West Cancer Center
Germantown, Tennessee, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States
The West Clinic, P.C. d/b/a West Cancer Center
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
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Shelbyville, Tennessee, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 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
Richmond, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
UZA
Edegem, Antwerpen, Belgium
GZA
Wilrijk, Antwerpen, Belgium
Institut Jules Bordet
Brussels, , Belgium
Sunnybrook Research Institute
Toronto, Ontario, Canada
McGill University Health Center- Cedars Cancer Center
Montreal, Quebec, Canada
McGill University Health Centre - Cedars Cancer Centre
Montreal, Quebec, Canada
Pharmacy Department
Dublin, , Ireland
Radiology Department
Dublin, , Ireland
St Vincent's University Hospital
Dublin, , Ireland
Institute for Cancer Research
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Pharmacy Department
Dublin, , Ireland
Radiology Department
Dublin, , Ireland
Cancer Clinical Trials Unit
Dublin, , Ireland
Pharmacy Department
Dublin, , Ireland
Radiology Department
Dublin, , Ireland
Institute for Cancer Research
Dublin, , Ireland
Mater Private Hospital
Dublin, , Ireland
Pharmacy Department
Dublin, , Ireland
Radiology Department
Dublin, , Ireland
IRCCS Ospedale San Raffaele
Milan, MI, Italy
Divisione di Senologia Medica; Istituto Europeo di Oncologia
Milan, MI, Italy
A.O.di Perugia S. Maria Della Misericoridia
Perugia, PG, Italy
Azienda Ospedaliera S.Orsola Malpighi
Bologna, , Italy
U.O. Farmaceutica, Nuovo Ospedale di Prato
Prato, , Italy
U.O. Oncologia Medica, Nuovo Ospedale di Prato
Prato, , Italy
Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain
Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 Octubre
Madrid, , Spain
Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital de Madrid Norte Sanchinarro
Madrid, , Spain
Brighton and Sussex University Hospital NHS Trust
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, England, United Kingdom
Clinical Investigation & Research Unit
Brighton, Sussex, United Kingdom
Countries
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Other Identifiers
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2013-002717-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3431008
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-12
Identifier Type: -
Identifier Source: org_study_id
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