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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
exemestane
Placebo (for enzalutamide)
exemestane
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring advanced breast cancer, enzalutamide, MDV3100, Estrogen receptor positive (ER +), Progesterone receptor positive (PgR +), HER-2 normal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • ATTN-Research Pharmacist
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • University of Colorado Hospital, Anschutz Outpatient Pavilion
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Northwestern Medical Faculty Foundation
  • Northwestern Memorial Hospital
  • The University of Chicago Medical Center,
  • The University of Chicago
  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  • Indiana University Health Hospital
  • Indiana University Health Melvin and Bren Simon Cancer Center
  • Investigational Drug Services
  • Sidney and Lois Eskenazi Hospital
  • Springmill Medical Clinic
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Minnesota Oncology Hematology, P.A
  • Abbott Northwestern Hospital
  • Allina Health System DBA Virginia Piper Cancer Institute
  • Dr.Michaela Tsai
  • The West Clinic, P.C.
  • The West Clinic, P.C. d/b/a West Cancer Center
  • Barnes-Jewish Hospital
  • Washington University Infusion Center Pharmacy
  • Washington University School of Medicine
  • Siteman Cancer Center-South County
  • Siteman Cancer Center- West County
  • Siteman Cancer Center
  • Hematology Oncology Associates of Northern NJ
  • Memorial Sloan Kettering Cancer Center
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Oncology Hematology Care, Inc.
  • Greenville Health System
  • Greenville Health System
  • Greenville Health System
  • The West Clinic, P.C. d/b/a West Cancer Center
  • The West Clinic, P.C. d/b/a West Cancer Center
  • The Sarah Cannon Research Institute
  • Vanderbilt Breast Center at One Hundred Oaks
  • Vanderbilt Health Pharmacy One Hundred Oaks
  • Tennessee Oncology, PLLC
  • Henry-Joyce Cancer Clinic
  • Investigational Products Center (IPC)
  • Investigational Products Center(IPC)
  • Investigational Products center
  • lnvestigational Products Center (IPC)
  • Texas Oncology - Memorial City
  • Texas Oncology-Longview Cancer Center
  • Texas Oncology - Tyler
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • UZA
  • GZA
  • Institut Jules Bordet
  • Sunnybrook Research Institute
  • McGill University Health Center- Cedars Cancer Center
  • McGill University Health Centre - Cedars Cancer Centre
  • Institute for Cancer Research
  • Mater Private Hospital
  • Pharmacy Department
  • Radiology Department
  • St Vincent's University Hospital
  • Institute for Cancer Research
  • Mater Private Hospital
  • Pharmacy Department
  • Radiology Department
  • Cancer Clinical Trials Unit
  • Pharmacy Department
  • Radiology Department
  • Pharmacy Department
  • Radiology Department
  • IRCCS Ospedale San Raffaele
  • Divisione di Senologia Medica; Istituto Europeo di Oncologia
  • A.O.di Perugia S. Maria Della Misericoridia
  • Azienda Ospedaliera S.Orsola Malpighi
  • IRCCS Ospedale San Raffaele
  • U.O. Farmaceutica, Nuovo Ospedale di Prato
  • U.O. Oncologia Medica, Nuovo Ospedale di Prato
  • Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena
  • Hospital Universitario HM Monteprincipe
  • Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Ramon Y Cajal
  • Hospital Universitario 12 Octubre
  • Centro Integral Oncologico Clara Campal
  • Hospital de Madrid Norte Sanchinarro
  • Brighton and Sussex University Hospital NHS Trust
  • Pharmacy Department
  • Radiation Safety Service, Medical Physics Department
  • Histopathology Department
  • Nottingham University Hospital
  • Pharmacy Department
  • Radiology Department
  • Radiology Department
  • Department of Radiology
  • Pharmacy Department
  • Royal Cornwall Hospitals NHS trust
  • Clinical Investigation & Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enzalutamide & exemestane

Placebo & exemestane

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)
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.
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS)
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

Clinical Benefit Rate-24 (CBR-24)
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.
Best Objective Response Rate
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.
Duration of Objective Response
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.
Time to Response
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.
Time to Progression
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.
Progression Free Survival (PFS) at 6 Months
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.
Concentration Versus Time Summary of Enzalutamide
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Concentration Versus Time Summary of Exemestane
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Concentration Versus Time Summary of N-desmethyl Enzalutamide
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.

Full Information

First Posted
December 3, 2013
Last Updated
April 25, 2023
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02007512
Brief Title
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 13, 2013 (Actual)
Primary Completion Date
September 23, 2016 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
advanced breast cancer, enzalutamide, MDV3100, Estrogen receptor positive (ER +), Progesterone receptor positive (PgR +), HER-2 normal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide & exemestane
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo & exemestane
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, XTANDI
Intervention Description
160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (for enzalutamide)
Intervention Description
Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)
Description
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.
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)
Title
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Clinical Benefit Rate-24 (CBR-24)
Description
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.
Time Frame
From randomization up to 3 years
Title
Best Objective Response Rate
Description
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.
Time Frame
From randomization until CR or PR, whichever occurred first (up to 3 years)
Title
Duration of Objective Response
Description
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.
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)
Title
Time to Response
Description
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.
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)
Title
Time to Progression
Description
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.
Time Frame
From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years)
Title
Progression Free Survival (PFS) at 6 Months
Description
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.
Time Frame
Month 6
Title
Concentration Versus Time Summary of Enzalutamide
Description
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Time Frame
Predose on Day 29, 57 and 113
Title
Concentration Versus Time Summary of Exemestane
Description
Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.
Time Frame
Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169
Title
Concentration Versus Time Summary of N-desmethyl Enzalutamide
Description
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.
Time Frame
Predose on Day 29, 57 and 113
Other Pre-specified Outcome Measures:
Title
European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30)
Time Frame
Month 24
Title
European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23)
Time Frame
Month 24
Title
Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC)
Time Frame
Day 1, 29, 57, 113 and 169
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
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)
Title
Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity
Description
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.
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)
Title
Number of Participants With Clinically Significant Vital Sign Abnormalities
Description
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.
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)
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Description
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.
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)
Title
Progression Free Survival (PFS): By Electronic Data Capture (EDC)
Description
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
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)
Title
Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC)
Description
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.
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
ATTN-Research Pharmacist
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Florida Cancer Specialists
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Cancer Specialists
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Facility Name
Florida Cancer Specialists
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Florida Cancer Specialists
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Florida Cancer Specialists
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33909
Country
United States
Facility Name
Florida Cancer Specialists
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33914
Country
United States
Facility Name
Florida Cancer Specialists
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Florida Cancer Specialists
City
Englewood
State/Province
Florida
ZIP/Postal Code
34223
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
Florida Cancer Specialists
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Florida Cancer Specialists
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Florida Cancer Specialists
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Florida Cancer Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Florida Cancer Specialists
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Cancer Specialists
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Florida Cancer Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Florida Cancer Specialists
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Florida Cancer Specialists
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34608
Country
United States
Facility Name
Florida Cancer Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida Cancer Specialists
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Florida Cancer Specialists
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Center,
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Drug Services
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Sidney and Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Springmill Medical Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Allina Health System DBA Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Dr.Michaela Tsai
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
The West Clinic, P.C.
City
Corinth
State/Province
Mississippi
ZIP/Postal Code
38834
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Infusion Center Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center- West County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Hematology Oncology Associates of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45202
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Greenville Health System
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Greenville Health System
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The West Clinic, P.C. d/b/a West Cancer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Breast Center at One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Vanderbilt Health Pharmacy One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Investigational Products Center (IPC)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Investigational Products Center(IPC)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Investigational Products center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
lnvestigational Products Center (IPC)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Facility Name
Texas Oncology - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology-Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Cancer Institute
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116-1844
Country
United States
Facility Name
Virginia Cancer Institute
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235-4730
Country
United States
Facility Name
UZA
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GZA
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University Health Center- Cedars Cancer Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
McGill University Health Centre - Cedars Cancer Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Institute for Cancer Research
City
Dublin 7
Country
Ireland
Facility Name
Mater Private Hospital
City
Dublin 7
Country
Ireland
Facility Name
Pharmacy Department
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Radiology Department
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
St Vincent's University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland
Facility Name
Institute for Cancer Research
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Mater Private Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Pharmacy Department
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Radiology Department
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Cancer Clinical Trials Unit
City
Dublin
ZIP/Postal Code
D9
Country
Ireland
Facility Name
Pharmacy Department
City
Dublin
ZIP/Postal Code
D9
Country
Ireland
Facility Name
Radiology Department
City
Dublin
ZIP/Postal Code
D9
Country
Ireland
Facility Name
Pharmacy Department
City
Dublin
Country
Ireland
Facility Name
Radiology Department
City
Dublin
Country
Ireland
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
Divisione di Senologia Medica; Istituto Europeo di Oncologia
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
A.O.di Perugia S. Maria Della Misericoridia
City
Perugia
State/Province
PG
ZIP/Postal Code
06132
Country
Italy
Facility Name
Azienda Ospedaliera S.Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
U.O. Farmaceutica, Nuovo Ospedale di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
U.O. Oncologia Medica, Nuovo Ospedale di Prato
City
Prato
ZIP/Postal Code
59100
Country
Italy
Facility Name
Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Hospital Universitario HM Monteprincipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Centro Integral Oncologico Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital de Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Brighton and Sussex University Hospital NHS Trust
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Pharmacy Department
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Radiation Safety Service, Medical Physics Department
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Histopathology Department
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Pharmacy Department
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Radiology Department
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Radiology Department
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Department of Radiology
City
Truro
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Pharmacy Department
City
Truro
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS trust
City
Truro
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Clinical Investigation & Research Unit
City
Brighton
State/Province
Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom

12. IPD Sharing Statement

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

Learn more about this trial

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

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