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
3 other identifiers
interventional
118
7 countries
132
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2013
Longer than P75 for phase_2
132 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedResults Posted
Study results publicly available
August 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2024
CompletedDecember 13, 2024
November 1, 2024
1.7 years
June 26, 2013
July 26, 2018
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (9)
Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population
Week 24
Percentage of Participants With Clinical Benefit at Week 24: ITT Population
Week 24
Percentage of Participants With Best Objective Response: Evaluable Population
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
From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
Progression-Free Survival (PFS): Evaluable Population
From Baseline up to disease progression or death due to any cause (up to 87 Weeks)
- +4 more secondary outcomes
Other Outcomes (6)
Trough Plasma Concentration of Enzalutamide and Its Metabolite
Predose on Day 1 (Baseline), Week 9 and Week 17
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 87 weeks
Number of Participants With Study Drug Discontinuation Due to Adverse Events
Baseline up to 87 weeks
- +3 more other outcomes
Study Arms (1)
Enzalutamide
EXPERIMENTAL160 mg administered as four 40 mg soft gelatin capsules orally once daily
Interventions
160 mg administered as four soft gelatin capsules orally once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (132)
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Center Sky Ridge
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124, United States
Florida Cancer Specialists
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34209, United States
Florida Cancer Specialists
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialist South Division
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Florida Cancer Specialists
Hudson, Florida, 34667, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists
Orange City, Florida, 32763, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories
Chicago, Illinois, 60611, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy
Chicago, Illinois, 60637, United States
The University of Chicago
Chicago, Illinois, 60637, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
Indiana University Health Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Investigational Drug Services
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Springmill Medical Clinic
Indianapolis, Indiana, 46290, United States
Oncology Hematology Care, Inc.
Crestview Hills, Kentucky, 41017, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
The West Clinic, PC
Corinth, Mississippi, 38834, United States
The West Clinic, PC
Southaven, Mississippi, 38671, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center-West County
St Louis, Missouri, 63141, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07962, United States
Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service
New York, New York, 10065, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Wesley Long Community Hospital
Greensboro, North Carolina, 27403, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care, Inc.
Fairfield, Ohio, 45014, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
Greenville Health System
Seneca, South Carolina, 29672, United States
Greenville Health System
Spartanburg, South Carolina, 29307, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37090, United States
The West Clinic, PC
Memphis, Tennessee, 38104, United States
The West Clinic, PC
Memphis, Tennessee, 38120, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt Health Pharmacy One Hundred Oaks
Nashville, Tennessee, 37204, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Texas Oncology - Longview Cancer Center
Longview, Texas, 75601, United States
Texas Oncology-Tyler
Tyler, Texas, 75702, United States
Virginia Cancer Institute
Mechanicsville, Virginia, 23116-1844, United States
Virginia Cancer Institute
Midlothian, Virginia, 23114, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Virginia Cancer Institute
Richmond, Virginia, 23235-4730, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
UZA
Edegem, Antwerpen, 2650, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, H4A 3J1, Canada
Department of Radiology
Dooradoyle, Limerick, Ireland
3rd Floor,Oncology Link office
Dublin, 4, Ireland
Department of Radiology
Dublin, 4, Ireland
Institute for Cancer Research
Dublin, 7, Ireland
Mater Private Hospital
Dublin, 7, Ireland
Pharmacy Department
Dublin, 7, Ireland
Radiology Department
Dublin, 7, 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, 20132, Italy
Farmacia (magazzino ricevimento merc), IRCCS Ospedale San Raffaele
Milan, 20132, Italy
U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi
Prato, 59100, Italy
U.O. Oncologia Medica, Nuovo Ospedale di Prato
Prato, 59100, Italy
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660, Spain
Grupo Hospitalario Quiron - Hospital Quiron Barcelona
Barcelona, 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 Octubre
Madrid, 28041, Spain
Centro Intergral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital de Madrid Norte-Sanchinarro.
Madrid, 28050, Spain
Clinical Investigation and Research Unit
Brighton, England, BN2 5BE, United Kingdom
Pharmacy Department
Brighton, England, BN2 5BE, United Kingdom
Radiation Safety Service, Medical Physics Department
Brighton, England, BN2 5BE, United Kingdom
Histopathology Department
Nottingham, England, NG5 1PB, United Kingdom
Nottingham University Hospital
Nottingham, England, NG5 1PB, United Kingdom
Pharmacy Department
Nottingham, England, NG5 1PB, United Kingdom
Radiology Department
Nottingham, England, NG5 1PB, United Kingdom
Radiology Department
Nottingham, England, NG7 2UH, United Kingdom
Department of Radiology
Truro, England, TR1 3LJ, United Kingdom
Pharmacy Department
Truro, England, TR1 3LJ, United Kingdom
Royal Cornwall Hospitals NHS trust
Truro, Cornwall, England, TR1 3LJ, United Kingdom
Related Publications (2)
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.
PMID: 35172518DERIVEDTraina 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.
PMID: 29373071DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
- STUDY CHAIR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
June 28, 2013
Study Start
June 12, 2013
Primary Completion
March 1, 2015
Study Completion
January 10, 2024
Last Updated
December 13, 2024
Results First Posted
August 22, 2018
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
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.