- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889238
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
February 7, 2024 updated by: Pfizer
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1000
- Institut Jules Bordet
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency - Vancouver Centre
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre-Cedars Cancer Centre
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Dublin, Ireland, 7
- Mater Private Hospital
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Dublin, Ireland, 7
- Institute for Cancer Research
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Dublin, Ireland, 7
- Pharmacy Department
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Dublin, Ireland, 7
- Radiology Department
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Dublin, Ireland, 4
- 3rd Floor,Oncology Link office
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Dublin, Ireland, 4
- Department of Radiology
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Dublin 4, Ireland
- Pharmacy Department
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Prato, Italy, 59100
- U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi
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Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 08023
- Grupo Hospitalario Quiron - Hospital Quiron Barcelona
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Madrid, Spain, 28034
- Hospital Universitario Ramon Y Cajal
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Madrid, Spain, 28041
- Hospital Universitario 12 Octubre
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Madrid, Spain, 28050
- Centro Intergral Oncologico Clara Campal
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Madrid, Spain, 28050
- Hospital de Madrid Norte-Sanchinarro.
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Madrid
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Boadilla del Monte, Madrid, Spain, 28660
- Hospital Universitario HM Monteprincipe
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England
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Brighton, England, United Kingdom, BN2 5BE
- Pharmacy Department
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Brighton, England, United Kingdom, BN2 5BE
- Radiation Safety Service, Medical Physics Department
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Brighton, England, United Kingdom, BN2 5BE
- Clinical Investigation and Research Unit
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Nottingham, England, United Kingdom, NG5 1PB
- Histopathology Department
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Nottingham, England, United Kingdom, NG5 1PB
- Nottingham University Hospital
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Nottingham, England, United Kingdom, NG5 1PB
- Pharmacy Department
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Nottingham, England, United Kingdom, NG7 2UH
- Radiology Department
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Truro, England, United Kingdom, TR1 3LJ
- Department of Radiology
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Truro, England, United Kingdom, TR1 3LJ
- Pharmacy Department
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Truro, Cornwall, England, United Kingdom, TR1 3LJ
- Royal Cornwall Hospitals NHS Trust
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers
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Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers
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Florida
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Altamonte Springs, Florida, United States, 32701
- Florida Cancer Specialists
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Bonita Springs, Florida, United States, 34135
- Florida Cancer Specialists
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Bradenton, Florida, United States, 34209
- Florida Cancer Specialists
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Brandon, Florida, United States, 33511
- Florida Cancer Specialists
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Cape Coral, Florida, United States, 33914
- Florida Cancer Specialists
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Clearwater, Florida, United States, 33761
- Florida Cancer Specialists
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Fort Myers, Florida, United States, 33916
- Florida Cancer Specialists
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Fort Myers, Florida, United States, 33905
- Florida Cancer Specialists
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Fort Myers, Florida, United States, 33908
- Florida Cancer Specialists
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Gainesville, Florida, United States, 32605
- Florida Cancer Specialists
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Hudson, Florida, United States, 34667
- Florida Cancer Specialists
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Largo, Florida, United States, 33770
- Florida Cancer Specialists
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Naples, Florida, United States, 34102
- Florida Cancer Specialists
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New Port Richey, Florida, United States, 34655
- Florida Cancer Specialists
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Orange City, Florida, United States, 32763
- Florida Cancer Specialists
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Orlando, Florida, United States, 32806
- Florida Cancer Specialists
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Port Charlotte, Florida, United States, 33980
- Florida Cancer Specialists
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Saint Petersburg, Florida, United States, 33705
- Florida Cancer Specialists
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Sarasota, Florida, United States, 34232
- Florida Cancer Specialists
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Sarasota, Florida, United States, 34236
- Florida Cancer Specialists
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Spring Hill, Florida, United States, 34608
- Florida Cancer Specialists
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Tampa, Florida, United States, 33607
- Florida Cancer Specialists
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Tavares, Florida, United States, 32778
- Florida Cancer Specialists
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Venice, Florida, United States, 34285
- Florida Cancer Specialists
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Venice, Florida, United States, 34292
- Florida Cancer Specialists
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Chicago, Illinois, United States, 60637
- The University Of Chicago
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy
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New Lenox, Illinois, United States, 60451
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- Sidney and Lois Eskenazi Hospital
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Indianapolis, Indiana, United States, 46202
- Indiana University Health Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States, 46202
- Indiana University Health Hospital
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Indianapolis, Indiana, United States, 46290
- Springmill Medical Clinic
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Indianapolis, Indiana, United States, 46202
- Investigational Drug Services
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Kentucky
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Crestview Hills, Kentucky, United States, 41017
- Oncology Hematology Care, Inc.
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Mississippi
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Corinth, Mississippi, United States, 38834
- The West Clinic, PC
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Southaven, Mississippi, United States, 38671
- The West Clinic, PC
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, United States, 63129
- Siteman Cancer Center-South County
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Saint Louis, Missouri, United States, 63110
- Washington University Infusion Center Pharmacy
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Saint Louis, Missouri, United States, 63141
- Siteman Cancer Center-West County
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Saint Peters, Missouri, United States, 63376
- Siteman Cancer Center
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New Jersey
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Morristown, New Jersey, United States, 07962
- Hematology Oncology Associates of Northern NJ
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10065
- Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service
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North Carolina
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Greensboro, North Carolina, United States, 27403
- Cone Health Cancer Center
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Greensboro, North Carolina, United States, 27403
- Wesley Long Community Hospital
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Ohio
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Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care, Inc.
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Cincinnati, Ohio, United States, 45230
- Oncology Hematology Care, Inc.
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Cincinnati, Ohio, United States, 45211
- Oncology Hematology Care, Inc.
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Cincinnati, Ohio, United States, 45236
- Oncology Hematology Care, Inc.
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Cincinnati, Ohio, United States, 45219
- Oncology Hematology Care, Inc.
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Fairfield, Ohio, United States, 45014
- Oncology Hematology Care, Inc.
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South Carolina
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Greenville, South Carolina, United States, 29605
- Greenville Health System
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Seneca, South Carolina, United States, 29672
- Greenville Health System
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Spartanburg, South Carolina, United States, 29307
- Greenville Health System
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Tennessee
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Dickson, Tennessee, United States, 37055
- Tennessee Oncology, PLLC
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Franklin, Tennessee, United States, 37067
- Tennessee Oncology, PLLC
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Gallatin, Tennessee, United States, 37066
- Tennessee Oncology, PLLC
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Hermitage, Tennessee, United States, 37076
- Tennessee Oncology, PLLC
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Lebanon, Tennessee, United States, 37087
- Tennessee Oncology, PLLC
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Memphis, Tennessee, United States, 38120
- The West Clinic, PC
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Memphis, Tennessee, United States, 38104
- The West Clinic, PC
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Murfreesboro, Tennessee, United States, 37129
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37203
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37203
- The Sarah Cannon Research Institute
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Nashville, Tennessee, United States, 37232
- Henry-Joyce Cancer Clinic
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Nashville, Tennessee, United States, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Nashville, Tennessee, United States, 37205
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37207
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37211
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37204
- Vanderbilt Health Pharmacy One Hundred Oaks
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Smyrna, Tennessee, United States, 37167
- Tennessee Oncology, PLLC
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Texas
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Dallas, Texas, United States, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Longview, Texas, United States, 75601
- Texas Oncology - Longview Cancer Center
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Tyler, Texas, United States, 75702
- Texas Oncology-Tyler
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Virginia
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Mechanicsville, Virginia, United States, 23116-1844
- Virginia Cancer Institute
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Midlothian, Virginia, United States, 23114
- Virginia Cancer Institute
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Newport News, Virginia, United States, 23606
- Virginia Oncology Associates
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Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
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Richmond, Virginia, United States, 23230
- Virginia Cancer Institute
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Richmond, Virginia, United States, 23235-4730
- Virginia Cancer Institute
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Virginia Beach, Virginia, United States, 23456
- Virginia Oncology Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Enzalutamide
160 mg administered as four 40 mg soft gelatin capsules orally once daily
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160 mg administered as four soft gelatin capsules orally once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population
Time Frame: Week 16
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Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >= 16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1).
An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis.
PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference
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Week 16
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Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population
Time Frame: Week 16
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Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1.
An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis.
PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population
Time Frame: Week 24
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Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1.
An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis.
PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
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Week 24
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Percentage of Participants With Clinical Benefit at Week 24: ITT Population
Time Frame: Week 24
|
Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1.
An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis.
PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.
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Week 24
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Percentage of Participants With Best Objective Response: Evaluable Population
Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
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Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis.
PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
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From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
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Percentage of Participants With Best Objective Response: ITT Population
Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
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Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1.
As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis.
PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.
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From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
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Progression-Free Survival (PFS): Evaluable Population
Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
|
PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1.
As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
|
From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
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Progression-Free Survival: ITT Population
Time Frame: From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
|
PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1.
As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
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From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trough Plasma Concentration of Enzalutamide and Its Metabolite,
Time Frame: Predose on Day 1 (Baseline), Week 9 and Week 17
|
M2 was the metabolite of enzalutamide.
The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/ml) for enzalutamide and M2.
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Predose on Day 1 (Baseline), Week 9 and Week 17
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 87 weeks
|
An AEs was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment emergent are events between first dose of study drug and up to 87 weeks that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non-serious AEs.
|
Baseline up to 87 weeks
|
Number of Participants With Study Drug Discontinuation Due to Adverse Events
Time Frame: Baseline up to 87 weeks
|
Baseline up to 87 weeks
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Time Frame: Baseline up to 87 weeks
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
As per the NCI CTCAE, version 4.0, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death.
Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure.
|
Baseline up to 87 weeks
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Baseline up to 87 weeks
|
Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit or 2 consecutive visits SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM.
Only those categories, in which at least 1 subject had data were reported.
|
Baseline up to 87 weeks
|
Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades
Time Frame: Baseline up to 87 weeks
|
Laboratory tests included hematology parameters (low lymphocytes, WBC, neutrophils, hemoglobin and platelets) and chemistry parameters (mean albumin, Blood urea nitrogen [BUN], calcium, Lactate dehydrogenase [LDH], alanine aminotransferase, Aspartate aminotransferase , bilirubin, Alkaline phosphatase, creatinine and glucose).
Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per National Cancer Institute Common Terminology Criteria (NCI CTC) (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.
|
Baseline up to 87 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Pfizer CT.gov Call Center, Pfizer
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2013
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
January 10, 2024
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimated)
June 28, 2013
Study Record Updates
Last Update Posted (Actual)
February 12, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDV3100-11
- 2013-000698-57 (EudraCT Number)
- C3431007 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); Genentech, Inc.TerminatedTriple Negative Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | Estrogen Receptor Negative Breast CancerUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI); Merck Sharp & Dohme LLCCompletedStage IV Breast Cancer | Estrogen Receptor Negative | Estrogen Receptor Positive | HER2/Neu Negative | Progesterone Receptor Negative | Progesterone Receptor Positive | Triple-Negative Breast CarcinomaUnited States
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HutchmedActive, not recruitingRectal Cancer | Advanced Solid Tumors | Metastatic Breast Cancer | Triple Negative Breast Cancer | Metastatic Colon Cancer | Hormone Receptor Positive Breast Carcinoma | HER2-negative Breast CancerUnited States
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QuantumLeap Healthcare CollaborativeRecruitingBreast Cancer | Breast Neoplasms | Breast Tumors | HER2-positive Breast Cancer | Angiosarcoma | Locally Advanced Breast Cancer | HER2-negative Breast Cancer | TNBC - Triple-Negative Breast Cancer | Hormone Receptor Positive Tumor | Hormone Receptor Negative Tumor | Early-stage Breast CancerUnited States
Clinical Trials on Enzalutamide
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ESSA PharmaceuticalsRecruitingProstate CancerCanada, United States, Australia
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Astellas Pharma Europe B.V.Medivation, Inc.CompletedProstate Cancer | Pharmacokinetics of EnzalutamideUnited States
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Radboud University Medical CenterActive, not recruitingProstatic Neoplasms, Castration-ResistantNetherlands
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Groupe Hospitalier Pitie-SalpetriereCompletedEpilepsy | Prostate Cancer | Neuropathy | EncephalopathyFrance
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Andreas JosefssonGöteborg University; Umeå University; Sahlgrenska University Hospital, Sweden; Sundsvall... and other collaboratorsTerminated
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Hinova Pharmaceuticals Inc.CompletedMetastatic Castration Resistant Prostate CancerChina
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Macquarie University, AustraliaUnknown
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Fundación Canaria de Investigación SanitariaHospital Universitario de CanariasUnknown
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Translational Research Center for Medical Innovation...Kagawa UniversityCompleted
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Alessa Therapeutics Inc.National Cancer Institute (NCI)Not yet recruitingProstate AdenocarcinomaUnited States