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Clinical Trials (PDQ®)

Exemestane With or Without Entinostat in Treating Postmenopausal Patients With Recurrent Hormone Receptor-Positive Breast Cancer That Is Locally Advanced or Metastatic

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overNCINCI-2014-00746
ECOG-E2112, E2112, U10CA021115, U10CA180820, NCT02115282

Trial Description

Summary

This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body. Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To evaluate whether the addition of entinostat to endocrine therapy (exemestane) improves progression-free survival (PFS) and/or overall survival (OS) in postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have previously progressed on a non-steroidal aromatase inhibitor (Al).

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of entinostat in combination with exemestane, and to compare the safety profile to that of endocrine therapy with placebo.

II. To evaluate the objective response rate of exemestane in combination with entinostat or placebo.

III. To evaluate whether the efficacy of exemestane with entinostat varies with changes in acetylation status in peripheral blood mononuclear cells (PBMCs).

IV. To evaluate the time to treatment deterioration (as defined by decrease in health-related quality of life [HRQL], progression, death) of exemestane + entinostat versus exemestane + placebo arms.

V. To evaluate the differences in overall health-related quality of life (HRQL) between the exemestane + entinostat versus exemestane + placebo arms.

VI. To evaluate the difference with respect to specific symptoms that are associated with entinostat, i.e., fatigue, nausea, anorexia and diarrhea, between the exemestane + entinostat versus exemestane + placebo arms.

VII. To measure adherence to protocol therapy.

TERTIARY OBJECTIVES:

I. To collect archival tumor samples and germline deoxyribonucleic acid (DNA) to explore other potential biomarkers of therapeutic efficacy.

II. To collect patient ratings of adverse events (AEs) using select patient-reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items to evaluate the psychometric properties of PRO-CTCAE items and explore the incorporation of PRO-CTCAE items into a phase III double-blind placebo-controlled trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive exemestane orally (PO) once daily (QD) on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

In both arms, male patients also receive goserelin acetate subcutaneously (SC) on day 1.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

Eligibility Criteria

Inclusion Criteria:

  • Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of >= 1% cells will be considered positive; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)
  • Patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)
  • Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved
  • NOTE: Where baseline imaging has already been performed =< 6 weeks prior to study randomization, repeat imaging may not be required
  • Postmenopausal women and all men are eligible for this trial; postmenopausal is defined as:
  • Age >= 55 years and one year or more of amenorrhea
  • Age < 55 years and one year or more of amenorrhea, with estradiol < 20 pg/ml
  • Age < 55 with prior hysterectomy but intact ovaries, with estradiol < 20 pg/ml
  • Prior bilateral oophorectomy NOTE: Men can enroll provided they agree to receive concomitant luteinizing hormone-releasing hormone (LHRH) agonist; LHRH agonist use is not permitted for female patients
  • Sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy
  • Patients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases; patients with leptomeningeal disease are not eligible
  • Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; NOTE: if there is a history of prior malignancy, patients must not be receiving other specific treatment for that cancer
  • Patients must meet at least one of the following criteria:
  • Disease progression after non-steroidal aromatase inhibitor (AI) use in the metastatic setting
  • Relapse while on or within =< 12 months of end of adjuvant non-steroidal AI therapy with no prior or =< 4 weeks of endocrine therapy for metastatic disease
  • NOTE: Prior exemestane or fulvestrant is not allowed; prior everolimus therapy is allowed and must have been completed 2 weeks prior to study entry; other prior endocrine therapy for metastatic disease is allowed (e.g. tamoxifen) and must have been completed 2 weeks prior to study entry
  • Patients may have received one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization
  • Patients may be treated with bone modifying agents such as bisphosphonates or receptor activator of nuclear factor kappa-B (RANK)-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
  • Prior radiotherapy must in general have been completed >= 2 weeks prior to randomization and patients must have recovered from the toxicity of the radiation; NOTE: patients may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as sites of measurable or non-measurable disease outside the radiation therapy port are available to follow
  • Patients must NOT receive concurrent anti-cancer therapy or investigational agent unless specified in protocol
  • Patients must NOT be receiving valproic acid, an histone deacetylase (HDAC) inhibitor, and may not have previously received any HDAC inhibitor prior to enrollment (e.g. valproic acid, entinostat, vorinostat)
  • Patients must have no known allergies to imidazole drugs (e.g. clotrimazole, ketoconazole, miconazole, econazole, sulconazole, ticonazole, or terconazole), exemestane or entinostat
  • Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infection
  • Patients must have recovered from all clinically relevant adverse events to grade 1 or baseline due to previous agents administered (except alopecia)
  • Patients must have adequate hematologic, liver and renal function =< 28 days prior to randomization; NOTE: it is preferred that laboratory values for eligibility be assessed after the last dose of prior treatment, especially in cases where most-recent treatment prior to study entry is chemotherapy
  • Hemoglobin (HgB) >= 9.0 g/dL
  • Platelet count >= 100,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Creatinine =< 2.0 mg/dL
  • Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert's syndrome)
  • Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 x institutional upper limit normal
  • Known human immunodeficiency virus (HIV)-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patients must have a life expectancy >= 12 weeks
  • Patients must be able to swallow tablets

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Roisin ConnollyPrincipal Investigator

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Carla I. Falkson Ph: 205-934-0309
California
  Paradise
 Feather River Hospital Cancer Center
 Sam Mazj Ph: 530-876-7995
  Email: haleew@ah.org
  Saint Helena
 Saint Helena Hospital
 Gregory B Smith Ph: 707-967-3698
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Aurora
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Boulder
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers at the Pavilion
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Colorado Blood Cancer Institute
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Denver Midtown
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers-Rose
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Durango
 Mercy Medical Center
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Comprehensive Cancer Care and Research Institute of Colorado LLC
 Keren Sturtz Ph: 888-785-6789
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Golden
 Mountain Blue Cancer Care Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greenwood Village
 Breast Cancer Care Consultants
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 Rocky Mountain Cancer Centers-Lakewood
 Keren Sturtz Ph: 888-785-6789
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Littleton
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Rocky Mountain Cancer Centers - Lone Tree
 Keren Sturtz Ph: 888-785-6789
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Longmont
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Rocky Mountain Cancer Centers - Parker
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 Rocky Mountain Cancer Centers - Pueblo
 Keren Sturtz Ph: 888-785-6789
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Thornton
 Rocky Mountain Cancer Centers - Thornton
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Middletown
 Middlesex Hospital Cancer Center
 Susanna Hong Ph: 860-358-2058
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Brian J Byrne Ph: 860-224-5660
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
 Stephen Scott Grubbs Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Stephen Scott Grubbs Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Stephen Scott Grubbs Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
District of Columbia
  Washington
 Sibley Memorial Hospital
 Roisin M Connolly Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi L. Venigalla Ph: 863-904-1900
Georgia
  Atlanta
 Georgia Cancer Center for Excellence at Grady Memorial Hospital
 Ruth M. O'Regan Ph: 404-778-1868
 Winship Cancer Institute of Emory University
 Ruth M. O'Regan Ph: 404-778-1868
 Ruth M. O'Regan Ph: 404-778-1868
  Macon
 Medical Center of Central Georgia
 Frederick M. Schnell Ph: 404-501-3279
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 Jennifer Yannucci Ph: 912-350-8568
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith M. Rowland Ph: 800-446-5532
  Bloomington
 Illinois CancerCare - Bloomington
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 St. Joseph Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Canton
 Illinois CancerCare - Canton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Carthage
 Illinois CancerCare - Carthage
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Decatur
 Cancer Care Center of Decatur
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
 Decatur Memorial Hospital Cancer Care Institute
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Effingham
 Crossroads Cancer Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Elk Grove Village
 Cancer Institute at Alexian Brothers
 Bruce B. Bank Ph: 847-952-7164
  Email: fredianc@alexian.net
  Eureka
 Illinois CancerCare - Eureka
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Galesburg
 Galesburg Clinic, PC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 InterCommunity Cancer Center of Western Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kulumani M Sivarajan Ph: 815-730-3098
  Email: maureenc@jolietoncology.com
  Kewanee
 Illinois CancerCare - Kewanee Clinic
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Macomb
 Illinois CancerCare - Macomb
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Ottawa
 Illinois CancerCare - Ottawa
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Radiation Oncology of Northern Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Pekin
 Cancer Treatment Center at Pekin Hospital
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Illinois CancerCare - Pekin
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peoria
 Illinois CancerCare - Peoria
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Methodist Medical Center of Illinois
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 OSF St. Francis Medical Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
 Valley Cancer Center
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Rockford
 Advanced Care and Treatment Medical Group, PC
 Harvey Eric Einhorn Ph: 779-696-9400
  Email: cancercare@swedishamerican.org
  Springfield
 Regional Cancer Center at Memorial Medical Center
 James L. Wade Ph: 217-876-4740
  Email: kcheek@dmhhs.org
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Kendrith M. Rowland Ph: 800-446-5532
  Yorkville
 Rush-Copley Healthcare Center
 Kendrith M. Rowland Ph: 800-446-5532
Indiana
  Indianapolis
 Central Indiana Cancer Centers - East
 Keith W Logie Ph: 317-356-2422
 Indiana University Melvin and Bren Simon Cancer Center
 Kathy Miller Ph: 317-274-2552
 Spring Mill Medical Center
 Kathy Miller Ph: 317-274-2552
 William N. Wishard Memorial Hospital
 Kathy Miller Ph: 317-274-2552
  Muncie
 Cancer Center at Ball Memorial Hospital
 Michael J Williamson Ph: 765-751-5850
  Email: alpatterson@medicalconsultantspc.com
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
 William R. Bliss Cancer Center at Mary Greeley Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Hematology Oncology Associates of the Quad Cities
 Shobha R. Chitneni Ph: 563-355-7733
  Email: kedaprile@rccqc.com
  Boone
 McFarland Clinic PC-Boone
 Joseph James Merchant Ph: 515-239-2621
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Davenport
 Genesis Regional Cancer Center at Genesis Medical Center
 George Kovach Ph: 800-446-6088
  Email: werners@genesishealth.com
  Fort Dodge
 Trinity Regional Medical Center
 Joseph James Merchant Ph: 515-239-2621
  Jefferson
 McFarland Clinic PC-Jefferson
 Joseph James Merchant Ph: 515-239-2621
  Marshalltown
 McFarland Clinic PC-Marshalltown
 Joseph James Merchant Ph: 515-239-2621
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
Louisiana
  New Orleans
 Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
Maine
  Augusta
 Harold Alfond Center for Cancer Care
 Thomas Henry Openshaw Ph: 207-973-4274
  Rockport
 Penobscot Bay Medical Center Cancer Care Center
 Thomas Henry Openshaw Ph: 207-973-4274
  York
 York Hospital's Oncology Treatment Center
 Jonathan D Eneman Ph: 207-351-3777
Maryland
  Baltimore
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Roisin M Connolly Ph: 410-955-8804
  Email: jhcccro@jhmi.edu
  Easton
 Shore Regional Cancer Center at Memorial Hospital - Easton
 Mary S. DeShields Ph: 410-820-6800ext108
  Email: srichter@shorehealth.org
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Christopher M Reynolds Ph: 734-712-4673
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Flint
 Genesys Hurley Cancer Institute
 Christopher M Reynolds Ph: 734-712-4673
 Hurley Medical Center
 Christopher M Reynolds Ph: 734-712-4673
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Christopher M Reynolds Ph: 734-712-4673
  Livonia
 St. Mary Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Christopher M Reynolds Ph: 734-712-4673
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Christopher M Reynolds Ph: 734-712-4673
  Warren
 St. John Macomb Hospital
 Christopher M Reynolds Ph: 734-712-4673
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Brainerd
 St. Joseph's Medical Center
 Bret E Friday Ph: 888-203-7267
  Duluth
 CCOP - Duluth
 Bret E Friday Ph: 888-203-7267
Mississippi
  Hattiesburg
 Forrest General Cancer Center at Forrest General Hospital
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
 Hattiesburg Clinic, PA at Forrest General
 Augusto C Ochoa Ph: 504-568-2428
  Email: emede1@lsuhsc.edu
Missouri
  Bonne Terre
 Parkland Health Center-Bonne Terre
 Alan Philip Lyss Ph: 800-392-0936
  Branson
 Skaggs Cancer Center at Skaggs Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Chesterfield
 Saint Luke's Hospital
 Donald F. Busiek Ph: 314-205-6936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Mercy Clinic St. Louis Cancer and Breast Institute
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Sainte Genevieve
 Sainte Genevieve County Memorial Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Hulston Cancer Center at Cox Medical Center South
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Sullivan
 Missouri Baptist Sullivan Hospital
 Alan Philip Lyss Ph: 800-392-0936
  Sunset Hills
 Missouri Baptist Outpatient Center-Sunset Hills
 Alan Philip Lyss Ph: 800-392-0936
Montana
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
New Hampshire
  Dover
 Seacoast Cancer Center at Wentworth - Douglass Hospital
 Barbara Shea Ph: 603-740-2150
New Jersey
  Hackensack
 CCOP - Northern New Jersey
 Donna T McNamara Ph: 201-996-2879
  Vineland
 Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare
 Carl J. Minniti Ph: 856-641-7933
New Mexico
  Albuquerque
 Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
 Ursa A Brown-Glaberman Ph: 505-272-6972
 University of New Mexico Cancer Center
 Ursa A Brown-Glaberman Ph: 505-272-6972
  Las Cruces
 Memorial Medical Center
 Ursa A Brown-Glaberman Ph: 505-272-6972
  Santa Fe
 New Mexico Cancer Care Associates
 Ursa A Brown-Glaberman Ph: 505-272-6972
New York
  Bronx
 Jack D. Weiler Hospital at Montefiore Medical Center - East Campus
 Christine M. Pellegrino Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
 Montefiore Medical Center
 Christine M. Pellegrino Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  White Plains
 Dickstein Cancer Treatment Center at White Plains Hospital Center
 Karen B Green Ph: 914-681-2290
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Cameron B Harkness Ph: 828-670-8403
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
 Hendersonville Hematology and Oncology
 James E. Radford Ph: 828-696-4716
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
  Washington
 Marion L. Shepard Cancer Center at Beaufort County Hospital
 John J Inzerillo Ph: 252-975-4308ext104
  Email: sbell@brhealthsystem.org
North Dakota
  Bismarck
 Medcenter One Hospital Cancer Care Center
 Preston D. Steen Ph: 701-234-6161
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
  Minot
 Trinity CancerCare Center
 Stephen N Makoni Ph: 800-862-0005
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Esther H. Rehmus Ph: 330-344-6348
 Summa Center for Cancer Care at Akron City Hospital
 Jennifer E Payne Ph: 330-375-6101
  Belpre
 Strecker Cancer Center-Belpre
 J. Philip Kuebler Ph: 614-566-3275
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 Columbus Oncology Associates, Incorporated
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 614-566-3275
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Zangmeister Center
 J. Philip Kuebler Ph: 614-566-3275
  Delaware
 Delaware Health Center
 J. Philip Kuebler Ph: 614-566-3275
 Delaware Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Lima
 St. Rita's Medical Center
 Henry Gerad Ph: 419-226-9617
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Newark Radiation Oncology
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Oklahoma
  Lawton
 Cancer Centers of Southwest Oklahoma, LLC - Lawton
 Nadim F. Nimeh Ph: 877-231-4440
Pennsylvania
  Chadds Ford
 Christiana Care Concord Health Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Lancaster
 Lancaster General Hospital
 Elizabeth Horenkamp Ph: 717-544-5511
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Jennifer Y Shih Ph: 215-728-4790
  Pittsburgh
 UPMC Cancer Centers
 Shannon L Puhalla Ph: 412-647-2811
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Terrence P. Cescon Ph: 610-988-9323
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Mark T Schroeder Ph: 605-716-3982
  Email: research@rcrh.org
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Virginia
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
Washington
  Bremerton
 Olympic Hematology and Oncology
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Edmonds
 Swedish Cancer Institute at Stevens Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
  Seattle
 Group Health Central Hospital
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Minor and James Medical, PLLC
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
 Gary E Goodman Ph: 206-386-2323
  Email: patra.grevstad@swedish.org
Wisconsin
  Burlington
 Aurora Cancer Care-Burlington
 Rubina Qamar Ph: 888-709-2080
  Elkhorn
 Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
 Rubina Qamar Ph: 888-709-2080
  Grafton
 Aurora Cancer Care-Grafton
 Rubina Qamar Ph: 888-709-2080
  Green Bay
 Bellin Memorial Hospital
 Patrick J Mansky Ph: 920-435-8326
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Rubina Qamar Ph: 888-709-2080
  Kenosha
 Oncology Alliance - Kenosha South
 Rubina Qamar Ph: 888-709-2080
  Marinette
 Vince Lombardi Cancer Clinic - Marinette
 Rubina Qamar Ph: 888-709-2080
  Menomonee Falls
 Aurora Advanced Healthcare Inc-Menomonee Falls
 Rubina Qamar Ph: 888-709-2080
  Milwaukee
 Aurora Cancer Care-Milwaukee
 Rubina Qamar Ph: 888-709-2080
 Aurora Sinai Medical Center
 Rubina Qamar Ph: 888-709-2080
 Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
 Rubina Qamar Ph: 888-709-2080
  Mukwonago
 D.N. Greenwald Center
 Timothy R Wassenaar Ph: 262-928-7878
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Timothy R Wassenaar Ph: 262-928-7878
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Rubina Qamar Ph: 888-709-2080
  Racine
 Aurora Health Center - Racine
 Rubina Qamar Ph: 888-709-2080
  Sheboygan
 Vince Lombardi Cancer Clinic - Sheboygan
 Rubina Qamar Ph: 888-709-2080
  Summit
 Aurora Medical Center
 Rubina Qamar Ph: 888-709-2080
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Rubina Qamar Ph: 888-709-2080
  Waukesha
 Aurora Cancer Care-Waukesha
 Rubina Qamar Ph: 888-709-2080
 Waukesha Memorial Hospital Regional Cancer Center
 Timothy R Wassenaar Ph: 262-928-7878
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar Ph: 888-709-2080
  West Allis
 Aurora Women's Pavilion of West Allis Memorial Hospital
 Rubina Qamar Ph: 888-709-2080

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT02115282
ClinicalTrials.gov processed this data on October 15, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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