Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
Breast Cancer
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
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
Experimental
Active Comparator
Enzalutamide & exemestane
Placebo & exemestane
Enzalutamide 160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) once daily after food.
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.