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Could a prostate cancer drug help fight advanced breast cancer?

NCT ID NCT02007512

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 2 trial tested whether adding enzalutamide (a drug that blocks male hormones) to the standard hormone therapy exemestane could help slow advanced breast cancer in postmenopausal women. The study enrolled 247 participants with hormone receptor-positive, HER2-normal breast cancer. Researchers measured how long the cancer stayed under control and looked for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzalutamide (a hormone-blocking drug) combined with exemestane (an aromatase inhibitor)
What this could lead to
If successful, this combination could offer a new treatment option to slow cancer growth in advanced hormone-positive breast cancer.
What could go wrong
This is a Phase 2 trial with a moderate number of participants, so results may not confirm effectiveness. The combination may cause side effects or not work better than existing therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

247 people

The number who actually took part.

Started

Dec 2013

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

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

    Perugia, PG, 06132, Italy

  • ATTN-Research Pharmacist

    Aurora, Colorado, 80045, United States

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Allina Health System DBA Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407, United States

  • Azienda Ospedaliera S.Orsola Malpighi

    Bologna, 40138, Italy

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Brighton and Sussex University Hospital NHS Trust

    Brighton, England, BN2 5BE, United Kingdom

  • Cancer Clinical Trials Unit

    Dublin, D9, Ireland

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Clinical Investigation & Research Unit

    Brighton, Sussex, BN2 5BE, United Kingdom

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Department of Radiology

    Truro, England, TR1 3LJ, United Kingdom

  • Dipartimento di Oncologia Medica, Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Divisione di Senologia Medica; Istituto Europeo di Oncologia

    Milan, MI, 20141, Italy

  • Dr.Michaela Tsai

    Minneapolis, Minnesota, 55407, United States

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701, United States

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135, United States

  • Florida Cancer Specialists

    Bradenton, Florida, 34209, United States

  • Florida Cancer Specialists

    Brandon, Florida, 33511, United States

  • Florida Cancer Specialists

    Cape Coral, Florida, 33909, United States

  • Florida Cancer Specialists

    Clearwater, Florida, 33761, United States

  • Florida Cancer Specialists

    Englewood, Florida, 34223, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908, United States

  • Florida Cancer Specialists

    Gainesville, Florida, 32605, United States

  • Florida Cancer Specialists

    Hudson, Florida, 34667, United States

  • Florida Cancer Specialists

    Largo, Florida, 33770, United States

  • Florida Cancer Specialists

    Naples, Florida, 34102, United States

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655, United States

  • Florida Cancer Specialists

    Orange City, Florida, 32763, United States

  • Florida Cancer Specialists

    Orlando, Florida, 32806, United States

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34236, United States

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608, United States

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists

    Tampa, Florida, 33607, United States

  • Florida Cancer Specialists

    Tavares, Florida, 32778, United States

  • Florida Cancer Specialists

    Venice, Florida, 34285, United States

  • Florida Cancer Specialists

    Venice, Florida, 34292, United States

  • GZA

    Wilrijk, Antwerpen, 2610, Belgium

  • Greenville Health System

    Greenville, South Carolina, 29605, United States

  • Greenville Health System

    Seneca, South Carolina, 29672, United States

  • Greenville Health System

    Spartanburg, South Carolina, 29307, United States

  • Grupo Hospitalario Quiron - Hospital Universitari Quiron Dexeus

    Barcelona, 08028, Spain

  • Hematology Oncology Associates of Northern NJ

    Morristown, New Jersey, 07962, United States

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Histopathology Department

    Nottingham, England, NG5 1PB, United Kingdom

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 Octubre

    Madrid, 28041, Spain

  • Hospital Universitario HM Monteprincipe

    Boadilla del Monte, Madrid, 28660, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034, Spain

  • Hospital de Madrid Norte Sanchinarro

    Madrid, 28050, Spain

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132, Italy

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202, United States

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Institute for Cancer Research

    Dublin, 7, Ireland

  • Institute for Cancer Research

    Dublin, Ireland

  • Investigational Drug Services

    Indianapolis, Indiana, 46202, United States

  • Mater Private Hospital

    Dublin, 7, Ireland

  • Mater Private Hospital

    Dublin, Ireland

  • McGill University Health Center- Cedars Cancer Center

    Montreal, Quebec, H4A 3J1, Canada

  • McGill University Health Centre - Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Minnesota Oncology Hematology, P.A

    Minneapolis, Minnesota, 55404, United States

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Nottingham University Hospital

    Nottingham, England, NG5 1PB, United Kingdom

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45202, United States

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45211, United States

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45230, United States

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45236, United States

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242, United States

  • Oncology Hematology Care, Inc.

    Fairfield, Ohio, 45014, United States

  • Pharmacy Department

    Dublin, 4, Ireland

  • Pharmacy Department

    Dublin, 7, Ireland

  • Pharmacy Department

    Dublin, D9, Ireland

  • Pharmacy Department

    Dublin, Ireland

  • Pharmacy Department

    Brighton, England, BN2 5BE, United Kingdom

  • Pharmacy Department

    Nottingham, England, NG5 1PB, United Kingdom

  • Pharmacy Department

    Truro, England, TR1 3LJ, United Kingdom

  • Radiation Safety Service, Medical Physics Department

    Brighton, England, BN2 5BE, United Kingdom

  • Radiology Department

    Dublin, 4, Ireland

  • Radiology Department

    Dublin, 7, Ireland

  • Radiology Department

    Dublin, D9, Ireland

  • Radiology Department

    Dublin, Ireland

  • Radiology Department

    Nottingham, England, NG5 1PB, United Kingdom

  • Radiology Department

    Nottingham, England, NG7 2UH, United Kingdom

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907, United States

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228, United States

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124, United States

  • Royal Cornwall Hospitals NHS trust

    Truro, England, TR1 3LJ, United Kingdom

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center- West County

    St Louis, Missouri, 63141, United States

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129, United States

  • Springmill Medical Clinic

    Indianapolis, Indiana, 46290, United States

  • St Vincent's University Hospital

    Dublin, 4, Ireland

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5, Canada

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067, United States

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066, United States

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076, United States

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090, United States

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211, United States

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160, United States

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167, United States

  • Texas Oncology - Memorial City

    Houston, Texas, 77024, United States

  • Texas Oncology - Tyler

    Tyler, Texas, 75702, United States

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601, United States

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The University of Chicago

    Chicago, Illinois, 60637, United States

  • The University of Chicago Medical Center,

    Chicago, Illinois, 60637, United States

  • The West Clinic, P.C.

    Corinth, Mississippi, 38834, United States

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

    Southaven, Mississippi, 38671, United States

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

    Germantown, Tennessee, 38138, United States

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

    Memphis, Tennessee, 38104, United States

  • U.O. Farmaceutica, Nuovo Ospedale di Prato

    Prato, 59100, Italy

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

    Prato, 59100, Italy

  • UZA

    Edegem, Antwerpen, 2650, Belgium

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451, United States

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital, Anschutz Outpatient Pavilion

    Aurora, Colorado, 80045, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204, United States

  • Vanderbilt Health Pharmacy One Hundred Oaks

    Nashville, Tennessee, 37204, United States

  • Virginia Cancer Institute

    Mechanicsville, Virginia, 23116, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23230, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23235, United States

  • Washington University Infusion Center Pharmacy

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.