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AzTrials

Breast CancerPhase 2NCT02007512

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

A Phase 2 study testing Enzalutamide and exemestane in people with Breast Cancer, run by Pfizer at 135 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Enzalutamide and exemestane
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
247 participants
Where
135 sitesin 7 countries
Study dates
16 Dec 2013to 23 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

135 sites in 7 countries.

135 sites in 7 countries

United States89 sites

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • ATTN-Research Pharmacist

    Aurora, Colorado, 80045

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital, Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center,

    Chicago, Illinois, 60637

  • The University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45211

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • The West Clinic, P.C.

    Corinth, Mississippi, 38834

  • Florida Cancer Specialists

    Englewood, Florida, 34223

  • Oncology Hematology Care, Inc.

    Fairfield, Ohio, 45014

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

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

    Germantown, Tennessee, 38138

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Florida Cancer Specialists

    Hudson, Florida, 34667

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Investigational Drug Services

    Indianapolis, Indiana, 46202

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Clinic

    Indianapolis, Indiana, 46290

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601

  • Virginia Cancer Institute

    Mechanicsville, Virginia, 23116

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

    Memphis, Tennessee, 38104

  • Minnesota Oncology Hematology, P.A

    Minneapolis, Minnesota, 55404

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Allina Health System DBA Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Dr.Michaela Tsai

    Minneapolis, Minnesota, 55407

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07962

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt Health Pharmacy One Hundred Oaks

    Nashville, Tennessee, 37204

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Virginia Cancer Institute

    Richmond, Virginia, 23235

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Greenville Health System

    Seneca, South Carolina, 29672

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

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

    Southaven, Mississippi, 38671

  • Greenville Health System

    Spartanburg, South Carolina, 29307

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University Infusion Center Pharmacy

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center- West County

    St Louis, Missouri, 63141

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    Venice, Florida, 34285

  • Florida Cancer Specialists

    Venice, Florida, 34292

Other trials in United States

Ireland14 sites

  • Pharmacy Department

    Dublin, 4

  • Radiology Department

    Dublin, 4

  • St Vincent's University Hospital

    Dublin, 4

  • Institute for Cancer Research

    Dublin, 7

  • Mater Private Hospital

    Dublin, 7

  • Pharmacy Department

    Dublin, 7

  • Radiology Department

    Dublin, 7

  • Cancer Clinical Trials Unit

    Dublin, D9

  • Pharmacy Department

    Dublin, D9

  • Radiology Department

    Dublin, D9

  • Institute for Cancer Research

    Dublin

  • Mater Private Hospital

    Dublin

  • Pharmacy Department

    Dublin

  • Radiology Department

    Dublin

Other trials in Ireland

United Kingdom12 sites

  • Brighton and Sussex University Hospital NHS Trust

    Brighton, England, BN2 5BE

  • Pharmacy Department

    Brighton, England, BN2 5BE

  • Radiation Safety Service, Medical Physics Department

    Brighton, England, BN2 5BE

  • Clinical Investigation & Research Unit

    Brighton, Sussex, BN2 5BE

  • Histopathology Department

    Nottingham, England, NG5 1PB

  • Nottingham University Hospital

    Nottingham, England, NG5 1PB

  • Pharmacy Department

    Nottingham, England, NG5 1PB

  • Radiology Department

    Nottingham, England, NG5 1PB

  • Radiology Department

    Nottingham, England, NG7 2UH

  • Department of Radiology

    Truro, England, TR1 3LJ

  • Pharmacy Department

    Truro, England, TR1 3LJ

  • Royal Cornwall Hospitals NHS trust

    Truro, England, TR1 3LJ

Other trials in United Kingdom

Italy7 sites

  • Azienda Ospedaliera S.Orsola Malpighi

    Bologna, 40138

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

  • Divisione di Senologia Medica; Istituto Europeo di Oncologia

    Milan, MI, 20141

  • A.O.di Perugia S. Maria Della Misericoridia

    Perugia, PG, 06132

  • U.O. Farmaceutica, Nuovo Ospedale di Prato

    Prato, 59100

  • U.O. Oncologia Medica, Nuovo Ospedale di Prato

    Prato, 59100

  • Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena

    Roma, 00144

Other trials in Italy

Spain7 sites

  • Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid, 28660

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital de Madrid Norte Sanchinarro

    Madrid, 28050

Other trials in Spain

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZA

    Edegem, Antwerpen, 2650

  • GZA

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Canada3 sites

  • McGill University Health Center- Cedars Cancer Center

    Montreal, Quebec, H4A 3J1

  • McGill University Health Centre - Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Enzalutamide, exemestane, Placebo (for enzalutamide)
Keywords
advanced breast cancer, enzalutamide, MDV3100, Estrogen receptor positive (ER +), Progesterone receptor positive (PgR +), HER-2 normal
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called MDV3100, XTANDI

    160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.

  • exemestaneDrug

    Also called Aromasin

    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.

  • Placebo (for enzalutamide)Drug

    Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

  • exemestaneDrug

    Also called Aromasin

    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.

Study groups in NCT02007512
Study groupRoleWhat they receive
Enzalutamide & exemestaneExperimentalEnzalutamide 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.
Receives: Drug: Enzalutamide; Drug: exemestane
Placebo & exemestaneActive comparatorPlacebo 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.
Receives: Drug: exemestane; Drug: Placebo (for enzalutamide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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 outcomes (9)

  1. 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.

    Measured: From randomization up to 3 years

  2. 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.

    Measured: From randomization until CR or PR, whichever occurred first (up to 3 years)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years)

  6. 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.

    Measured: Month 6

  7. Concentration Versus Time Summary of Enzalutamide

    Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.

    Measured: Predose on Day 29, 57 and 113

  8. Concentration Versus Time Summary of Exemestane

    Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.

    Measured: Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169

  9. 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.

    Measured: Predose on Day 29, 57 and 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study start16 Dec 2013
  3. Primary completion23 Sep 2016
  4. Study completion23 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007512
Sponsor's protocol ID
MDV3100-12
Other IDs
2013-002717-35, C3431008
Status last verified
Aug 2025
First submitted
3 Dec 2013
Last updated
2 Sep 2025
Data monitoring committee
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide and exemestane in people with Breast Cancer, run by Pfizer at 135 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Ireland, United Kingdom, Italy, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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