Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer

• ClinicalTrials.gov Identifier: NCT02007512
• Recruitment Status: Active, not recruiting
• First Posted: December 10, 2013
• Results First Posted: February 6, 2018
• Last Update Posted: February 15, 2023
• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc; Medivation, Inc.
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Enzalutamide; Drug: exemestane; Drug: Placebo (for enzalutamide)	Phase 2

Detailed Description:

This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF EFFICACY AND SAFETY OF ENZALUTAMIDE IN COMBINATION WITH EXEMESTANE IN PATIENTS WITH ADVANCED BREAST CANCER THAT IS ESTROGEN OR PROGESTERONE RECEPTOR-POSITIVE AND HER2-NORMAL
• Actual Study Start Date: December 13, 2013
• Actual Primary Completion Date: September 23, 2016
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Enzalutamide; 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.; Other Names: MDV3100; XTANDI; Drug: 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 Name: Aromasin
Active Comparator: 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.	Drug: 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.; Other Name: Aromasin; Drug: Placebo (for enzalutamide); Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS) [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]
   PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
2. Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS) [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]
   PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.

Secondary Outcome Measures :

1. Clinical Benefit Rate-24 (CBR-24) [ Time Frame: From randomization up to 3 years ]
   CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions.
2. Best Objective Response Rate [ Time Frame: From randomization until CR or PR, whichever occurred first (up to 3 years) ]
   Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment.
3. Duration of Objective Response [ Time Frame: From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]
   Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff.
4. Time to Response [ Time Frame: From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years) ]
   Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.
5. Time to Progression [ Time Frame: From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years) ]
   Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first.
6. Progression Free Survival (PFS) at 6 Months [ Time Frame: Month 6 ]
   PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression.
7. Concentration Versus Time Summary of Enzalutamide [ Time Frame: Predose on Day 29, 57 and 113 ]
   Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
8. Concentration Versus Time Summary of Exemestane [ Time Frame: Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169 ]
   Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
9. Concentration Versus Time Summary of N-desmethyl Enzalutamide [ Time Frame: Predose on Day 29, 57 and 113 ]
   N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.

Other Outcome Measures:

1. European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30) [ Time Frame: Month 24 ]
2. European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23) [ Time Frame: Month 24 ]
3. Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC) [ Time Frame: Day 1, 29, 57, 113 and 169 ]
4. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]
   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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.
5. Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]
   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. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure.
6. Number of Participants With Clinically Significant Vital Sign Abnormalities [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]
   Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP <90 millimeters of mercury (mmHg) and decrease from baseline (DFB) >30 mmHg, absolute SBP>180 mmHg 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 >=140 mmHg, most extreme post-baseline SBP >=180 mmHg, most extreme SBP >=140 mmHg and >=20 mmHg CFB, most extreme SBP >=180 mmHg and >=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP > 105 mmHg and IFB >30 mmHg, absolute DBP <50 mmHg and DFB >20 mmHg, final visit or 2 consecutive visits DBP >=15 mmHg CFB, most extreme post-baseline DBP >=90 mmHg, most extreme post-baseline DBP >=105 mmHg, most extreme DBP >=90 mmHg and >=15 mmHg CFB, most extreme DBP >=105 mmHg and >=15 mmHg CFB; heart rate <50 beats per minute (BPM) and DFB >20 BPM or heart rate >120 BPM and IFB >30 BPM.
7. Number of Participants With Clinically Significant Laboratory Abnormalities [ Time Frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years) ]
   Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils [absolute] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate transaminase [AST], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator's judgment.
8. Progression Free Survival (PFS): By Electronic Data Capture (EDC) [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]
   PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1 was defined >=20 % increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. Cht 1: Enz + Exe = Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg; Cht 2: Enz + Exe= Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg
9. Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC) [ Time Frame: From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years) ]
   PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Willing and able to provide informed consent;
• 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 severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;
• 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.

Contacts and Locations

Locations

United States, Colorado

ATTN-Research Pharmacist

Aurora, Colorado, United States, 80045

University of Colorado Cancer Center - Anschutz Cancer Pavilion

Aurora, Colorado, United States, 80045

University of Colorado Hospital, Anschutz Outpatient Pavilion

Aurora, Colorado, United States, 80045

Rocky Mountain Cancer Centers

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

United States, Florida

Florida Cancer Specialists

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, 33909

Florida Cancer Specialists

Cape Coral, Florida, United States, 33914

Florida Cancer Specialists

Clearwater, Florida, United States, 33761

Florida Cancer Specialists

Englewood, Florida, United States, 34223

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

Florida Cancer Specialists

Fort Myers, Florida, United States, 33905

Florida Cancer Specialists

Fort Myers, Florida, United States, 33908

Florida Cancer Specialists

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

United States, Illinois

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States, 60611

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

The University of Chicago Medical Center,

Chicago, Illinois, United States, 60637

The University of Chicago

Chicago, Illinois, United States, 60637

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States, 60451

United States, Indiana

Indiana University Health Hospital

Indianapolis, Indiana, United States, 46202

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Investigational Drug Services

Indianapolis, Indiana, United States, 46202

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States, 46202

Springmill Medical Clinic

Indianapolis, Indiana, United States, 46290

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Minnesota

Minnesota Oncology Hematology, P.A

Minneapolis, Minnesota, United States, 55404

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States, 55407

Allina Health System DBA Virginia Piper Cancer Institute

Minneapolis, Minnesota, United States, 55407

Dr.Michaela Tsai

Minneapolis, Minnesota, United States, 55407

United States, Mississippi

The West Clinic, P.C.

Corinth, Mississippi, United States, 38834

The West Clinic, P.C. d/b/a West Cancer Center

Southaven, Mississippi, United States, 38671

United States, Missouri

Barnes-Jewish Hospital

Saint Louis, Missouri, United States, 63110

Washington University Infusion Center Pharmacy

Saint Louis, Missouri, United States, 63110

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Siteman Cancer Center-South County

Saint Louis, Missouri, United States, 63129

Siteman Cancer Center- West County

Saint Louis, Missouri, United States, 63141

Siteman Cancer Center

Saint Peters, Missouri, United States, 63376

United States, New Jersey

Hematology Oncology Associates of Northern NJ

Morristown, New Jersey, United States, 07962

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

United States, Ohio

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45202

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45211

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45230

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45236

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States, 45242

Oncology Hematology Care, Inc.

Fairfield, Ohio, United States, 45014

United States, South Carolina

Greenville Health System

Greenville, South Carolina, United States, 29605

Greenville Health System

Seneca, South Carolina, United States, 29672

Greenville Health System

Spartanburg, South Carolina, United States, 29307

United States, Tennessee

The West Clinic, P.C. d/b/a West Cancer Center

Germantown, Tennessee, United States, 38138

The West Clinic, P.C. d/b/a West Cancer Center

Memphis, Tennessee, United States, 38104

The Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States, 37204

Vanderbilt Health Pharmacy One Hundred Oaks

Nashville, Tennessee, United States, 37204

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37211

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

United States, Texas

Investigational Products Center (IPC)

Fort Worth, Texas, United States, 76177

Investigational Products Center(IPC)

Fort Worth, Texas, United States, 76177

Investigational Products center

Fort Worth, Texas, United States, 76177

lnvestigational Products Center (IPC)

Fort Worth, Texas, United States, 76177

Texas Oncology - Memorial City

Houston, Texas, United States, 77024

Texas Oncology-Longview Cancer Center

Longview, Texas, United States, 75601

Texas Oncology - Tyler

Tyler, Texas, United States, 75702

United States, Virginia

Virginia Cancer Institute

Mechanicsville, Virginia, United States, 23116-1844

Virginia Cancer Institute

Midlothian, Virginia, United States, 23114

Virginia Cancer Institute

Richmond, Virginia, United States, 23230

Virginia Cancer Institute

Richmond, Virginia, United States, 23235-4730

Belgium

UZA

Edegem, Antwerpen, Belgium, 2650

GZA

Wilrijk, Antwerpen, Belgium, 2610

Institut Jules Bordet

Brussels, Belgium, 1000

Canada, Ontario

Sunnybrook Research Institute

Toronto, Ontario, Canada, M4N 3M5

Canada, Quebec

McGill University Health Center- Cedars Cancer Center

Montreal, Quebec, Canada, H4A 3J1

McGill University Health Centre - Cedars Cancer Centre

Montreal, Quebec, Canada, H4A 3J1

Ireland

Institute for Cancer Research

Dublin 7, Ireland

Mater Private Hospital

Dublin 7, Ireland

Pharmacy Department

Dublin, Ireland, 4

Radiology Department

Dublin, Ireland, 4

St Vincent's University Hospital

Dublin, Ireland, 4

Institute for Cancer Research

Dublin, Ireland, 7

Mater Private Hospital

Dublin, Ireland, 7

Pharmacy Department

Dublin, Ireland, 7

Radiology Department

Dublin, Ireland, 7

Cancer Clinical Trials Unit

Dublin, Ireland, D9

Pharmacy Department

Dublin, Ireland, D9

Radiology Department

Dublin, Ireland, D9

Pharmacy Department

Dublin, Ireland

Radiology Department

Dublin, Ireland

Italy

IRCCS Ospedale San Raffaele

Milano, MI, Italy, 20132

Divisione di Senologia Medica; Istituto Europeo di Oncologia

Milano, MI, Italy, 20141

A.O.di Perugia S. Maria Della Misericoridia

Perugia, PG, Italy, 06132

Azienda Ospedaliera S.Orsola Malpighi

Bologna, Italy, 40138

IRCCS Ospedale San Raffaele

Milano, Italy, 20132

U.O. Farmaceutica, Nuovo Ospedale di Prato

Prato, Italy, 59100

U.O. Oncologia Medica, Nuovo Ospedale di Prato

Prato, Italy, 59100

Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena

Roma, Italy, 00144

Spain

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain, 28660

Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus

Barcelona, Spain, 08028

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Hospital Universitario Ramon Y Cajal

Madrid, Spain, 28034

Hospital Universitario 12 Octubre

Madrid, Spain, 28041

Centro Integral Oncologico Clara Campal

Madrid, Spain, 28050

Hospital de Madrid Norte Sanchinarro

Madrid, Spain, 28050

United Kingdom

Brighton and Sussex University Hospital NHS Trust

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

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, NG5 1PB

Radiology Department

Nottingham, England, United Kingdom, NG7 2UH

Department of Radiology

Truro, England, United Kingdom, TR1 3LJ

Pharmacy Department

Truro, England, United Kingdom, TR1 3LJ

Royal Cornwall Hospitals NHS trust

Truro, England, United Kingdom, TR1 3LJ

Clinical Investigation & Research Unit

Brighton, Sussex, United Kingdom, BN2 5BE

Sponsors and Collaborators

Pfizer

Astellas Pharma Inc

Medivation, Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02007512
• Other Study ID Numbers: MDV3100-12; 2013-002717-35 ( EudraCT Number ); C3431008 ( Other Identifier: Alias Study Number )
• First Posted: December 10, 2013
• Results First Posted: February 6, 2018
• Last Update Posted: February 15, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:

advanced breast cancer; enzalutamide; MDV3100; Estrogen receptor positive (ER +); Progesterone receptor positive (PgR +); HER-2 normal

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Exemestane; Antineoplastic Agents; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs