Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

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
• Conditions: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Enzalutamide

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • UZA
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency - Vancouver Centre
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre-Cedars Cancer Centre
• Ireland
  • Dublin, Ireland, 7
    • Mater Private Hospital
  • Dublin, Ireland, 7
    • Institute for Cancer Research
  • Dublin, Ireland, 7
    • Pharmacy Department
  • Dublin, Ireland, 7
    • Radiology Department
  • Dublin, Ireland, 4
    • 3rd Floor,Oncology Link office
  • Dublin, Ireland, 4
    • Department of Radiology
  • Dublin 4, Ireland
    • Pharmacy Department
  • Limerick, Ireland
    • Cancer Clinical Trials Unit, Mid-Western Cancer center
  • Limerick, Ireland
    • Pharmacy Department
  • Limerick
    • Dooradoyle, Limerick, Ireland
      • Department of Radiology
• Italy
  • Milano, Italy, 20132
    • Dipartimento di Oncologia Medica, IRCCS Ospedale San Raffaele
  • Milano, Italy, 20132
    • Farmacia (magazzino ricevimento merc), IRCCS Ospedale San Raffaele
  • Prato, Italy, 59100
    • U.O. Oncologia Medica, Nuovo Ospedale di Prato
  • Prato, Italy, 59100
    • U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain, 08023
    • Grupo Hospitalario Quiron - Hospital Quiron Barcelona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 Octubre
  • Madrid, Spain, 28050
    • Centro Intergral Oncologico Clara Campal
  • Madrid, Spain, 28050
    • Hospital de Madrid Norte-Sanchinarro.
  • Madrid
    • Boadilla del Monte, Madrid, Spain, 28660
      • Hospital Universitario HM Monteprincipe
• United Kingdom
  • England
    • 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
      • Clinical Investigation and Research Unit
    • Nottingham, England, United Kingdom, NG5 1PB
      • 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
      • Radiology Department
    • Truro, England, United Kingdom, TR1 3LJ
      • Department of Radiology
    • Truro, England, United Kingdom, TR1 3LJ
      • Pharmacy Department
    • Truro, Cornwall, England, United Kingdom, TR1 3LJ
      • Royal Cornwall Hospitals NHS Trust
• United States
  • Colorado
    • 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
      • Rocky Mountain Cancer Centers
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Center Sky Ridge
  • Florida
    • 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, 33916
      • 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, 33908
      • Florida Cancer Specialist South Division
    • 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
      • Florida Cancer Specialists
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy
    • New Lenox, Illinois, United States, 60451
      • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Sidney and Lois Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Hospital
    • Indianapolis, Indiana, United States, 46290
      • Springmill Medical Clinic
    • Indianapolis, Indiana, United States, 46202
      • Investigational Drug Services
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Oncology Hematology Care, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Mississippi
    • Corinth, Mississippi, United States, 38834
      • The West Clinic, PC
    • Southaven, Mississippi, United States, 38671
      • The West Clinic, PC
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63129
      • Siteman Cancer Center-South County
    • Saint Louis, Missouri, United States, 63110
      • Washington University Infusion Center Pharmacy
    • Saint Louis, Missouri, United States, 63141
      • Siteman Cancer Center-West County
    • Saint Peters, Missouri, United States, 63376
      • Siteman Cancer Center
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Hematology Oncology Associates of Northern NJ
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
    • Greensboro, North Carolina, United States, 27403
      • Wesley Long Community Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45230
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45211
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45236
      • Oncology Hematology Care, Inc.
    • Cincinnati, Ohio, United States, 45219
      • Oncology Hematology Care, Inc.
    • Fairfield, Ohio, United States, 45014
      • Oncology Hematology Care, Inc.
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Health System
    • Seneca, South Carolina, United States, 29672
      • Greenville Health System
    • Spartanburg, South Carolina, United States, 29307
      • Greenville Health System
  • Tennessee
    • 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, 37090
      • Tennessee Oncology, PLLC
    • Lebanon, Tennessee, United States, 37087
      • Tennessee Oncology, PLLC
    • Memphis, Tennessee, United States, 38120
      • The West Clinic, PC
    • Memphis, Tennessee, United States, 38104
      • The West Clinic, PC
    • Murfreesboro, Tennessee, United States, 37129
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • The Sarah Cannon Research Institute
    • Nashville, Tennessee, United States, 37232
      • Henry-Joyce Cancer Clinic
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt Breast Center at One Hundred Oaks
    • Nashville, Tennessee, United States, 37205
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37207
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37211
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt Health Pharmacy One Hundred Oaks
    • Smyrna, Tennessee, United States, 37167
      • Tennessee Oncology, PLLC
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Houston, Texas, United States, 77024
      • Texas Oncology - Memorial City
    • Longview, Texas, United States, 75601
      • Texas Oncology - Longview Cancer Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology-Tyler
  • Virginia
    • Mechanicsville, Virginia, United States, 23116-1844
      • Virginia Cancer Institute
    • Midlothian, Virginia, United States, 23114
      • Virginia Cancer Institute
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
    • Norfolk, Virginia, United States, 23502
      • Virginia Oncology Associates
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute
    • Richmond, Virginia, United States, 23235-4730
      • Virginia Cancer Institute
    • Virginia Beach, Virginia, United States, 23456
      • Virginia Oncology Associates

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: MDV3100; Xtandi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population	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.	Week 16
Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population	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.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population	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.	Week 24
Percentage of Participants With Clinical Benefit at Week 24: ITT Population	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.	Week 24
Percentage of Participants With Best Objective Response: Evaluable Population	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.	From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Percentage of Participants With Best Objective Response: ITT Population	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.	From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Progression-Free Survival (PFS): Evaluable Population	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)
Progression-Free Survival: ITT Population	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)
Time to Response: Evaluable Population	The time to response is defined as the time from the date of first dose of study drug to initial CR or PR. Participants without response of CR or PR before the data cutoff date were censored at the last tumor assessment date before the data cutoff. Kaplan-Meier method was used to summarize time to response.	From first dose of study drug until first documentation of CR or PR or data censoring date, whichever occurred first (up to 87 Weeks)
Duration of Response: Evaluable Population	Duration of objective response is defined as the time from initial CR or PR to documented disease progression or death due to any cause, whichever occurs first. Participants without disease progression or death due to any cause before the data cutoff date were censored at the last tumor assessment date before the data cutoff.	From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (up to 87 Weeks)
Number of Participants With Postbaseline Laboratory Toxicities Grade 3 or 4	Laboratory parameters included hematology parameters [low lymphocytes (10^6/L), neutrophils (10^6/L) and Leukocytes (10^9/L)] and chemistry parameters [high phosphate (mmol/L), bilirubin, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with postbaseline laboratory toxicity Grade 3 or 4 as per NCI-CTCAE (version 4.0) (Grade 3= Severe, Grade 4= Life-threatening) were reported.	From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trough Plasma Concentration of Enzalutamide and Its Metabolite	M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/mL) for enzalutamide and M2.	Predose on Day 1 (Baseline), Week 9 and Week 17
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE 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 that were absent before treatment or that worsened relative to pretreatment state between first dose of study drug and up to 30 days after last dose of study drug or the day prior to initiation of new anti-tumor treatment. AEs included both serious and non-serious AEs.	Baseline up to 87 weeks
Number of Participants With Study Drug Discontinuation Due to Adverse Events	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Data reported here is for study drug discontinuation due to adverse events.	Baseline up to 87 weeks
Number of Participants With Grade 3 or Higher Adverse Events	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 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	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 (FV) or 2 consecutive visits (CV) 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 participant had data were reported.	From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years)
Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades	Laboratory tests included hematology parameters [low lymphocytes (10^6/L), white blood cells (10^9/L), neutrophils (10^6/L), hemoglobin gram per Liter(g/L) and platelets (10^9/L)] and chemistry parameters [mean albumin grams per Liter(g/L), calcium milli mole per Liter(mmol/L), Phosphate (mmol/L), alanine aminotransferase units per Liter(U/L), Aspartate aminotransferase (U/L), bilirubin micro mole per Liter, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per NCI-CTCAE (version 4.0) (Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.	From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Investigators: Study Chair: Pfizer CT.gov Call Center, Pfizer; Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

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

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): December 13, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; triple negative; androgen receptor positive
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• 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.