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Trial record 1 of 1 for:    RAD1901-308
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Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778931
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Brief Summary:
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Elacestrant Drug: Standard of Care Phase 3

Detailed Description:
This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Elacestrant
Subjects in Arm 1 will receive elacestrant
Drug: Elacestrant
400 mg/day once daily oral dosing
Other Name: RAD1901

Active Comparator: Standard of Care (SoC)
Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Drug: Standard of Care
  • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle
  • Anastrozole 1 mg/day on a continuous dosing schedule
  • Letrozole: 2.5 mg/day on a continuous dosing schedule
  • Exemestane: 25 mg/day on a continuous dosing schedule
Other Name: Faslodex, Arimidex, Femara, Aromasin




Primary Outcome Measures :
  1. Progression Free Survival (PFS) in the ESR1-mut subjects [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months) ]
    Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects

  2. PFS in all (ESR1-mut and ESR1-WT) subjects [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months) ]
    PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects


Secondary Outcome Measures :
  1. Objective Survival (OS) in ESR1-mut subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]
    OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause

  2. OS in all (ESR1-mut and ESR1-WT) subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]
    OS in all (ESR1-mut and ESR1-WT) subjects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Critical Inclusion Criteria:

  1. Subjects with proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy.
  2. Subjects must be appropriate candidates for endocrine monotherapy
  3. Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease
  4. Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
  5. Subjects must have ER+/HER2-tumor status
  6. Subjects must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
  7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
  8. Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
  9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing before subject is randomized.

Critical Exclusion Criteria:

  1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.
  2. Prior anticancer or investigational drug treatment within the following windows:

    1. Fulvestrant treatment < 28 days before first dose of study drug
    2. Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
    3. Chemotherapy < 21 days before first dose of study drug
    4. Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor
  3. Presence of symptomatic visceral disease as defined in protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778931


Contacts
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Contact: Director, Clinical Operations 1-855-672-3487 clinopsinfo@radiuspharm.com
Contact: Clinical Operations, Radius clinopsinfo@radiuspharm.com

Locations
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United States, Arizona
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Kelly Myrdal    520-694-1948    kelly.myrdal@bannerhealth.com   
Contact: DeeAnn Emmons    520-694-9084    demnons1@email.arizona.edu   
Principal Investigator: Pavani Chalasani         
United States, Arkansas
St. Bernards Medical Center Recruiting
Jonesboro, Arkansas, United States, 72401
Principal Investigator: Mazen Khalil         
United States, California
St. Jude Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Eleazar Bautista    714-446-5652    eleazar.bautista@stjoe.org   
Contact: Giribala Patel    714-446-5900    giribala.patel@stjoe.org   
Principal Investigator: William Lawler, MD         
Adventist Health Glendale Recruiting
Glendale, California, United States, 91206
Contact: Javier Valeriano    818-409-8009    javier.valeriano@ah.org   
Principal Investigator: Mihran Shirinian, MD         
Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS) Recruiting
Los Angeles, California, United States, 90033
Contact: Shirley Sian    323-865-0456    sian_s@med.usc.edu   
Contact: Kristy Massopust    323-865-0843    massopust_k@med.usc.edu   
Principal Investigator: Charlene Chiu         
USC IDS Pharmacy Recruiting
Los Angeles, California, United States, 90033
Contact: Shirley Sian    323-865-0456    sian_s@med.usc.edu   
Contact: Kristy Massopust    323-865-0843    massopust_k@med.usc.edu   
Principal Investigator: Janice Lu         
Ridley Tree Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Brittany Braden    805-563-5800    bbraden@ccsb.org   
Contact: Kelly Schlingensiepen    805-879-5097    kschling@ridleytreecc.org   
Principal Investigator: Frederic Kass         
UCLA Hematology/Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-794-6500    MPRocha@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
UCLA West Medical Pharmacy 159 Recruiting
Los Angeles, California, United States, 90095
Contact: Raven Carter    260-969-7876    raven.carter@fwmoh.com   
Contact: Lori Miller    +1 260-484-8830    lmiller@fwmoh.com   
Principal Investigator: Sunil Babu         
TMPN Cancer Care Recruiting
Redondo Beach, California, United States, 90277
Contact: Courtey Steeneken    310-750-3382    courtney.steeneken@tmphysicians.com   
Principal Investigator: David Chen, MD         
UC Davis Medical Center, Investigational Drug Service Recruiting
Sacramento, California, United States, 95817
Contact: Teri Nguyen    916-734-8266    crcnguyen@ucdavis.edu   
Principal Investigator: Helen Chew         
Central Coastal Medical Oncology Recruiting
Santa Maria, California, United States, 93454
Contact: Lindsay McFarland    805-988-7083    lindsey.mcfarland@dignityhealth.org   
Principal Investigator: Robert Dichmann         
United States, Colorado
University of Colorado Hospital - Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    720-848-0664    tiffany.colvin@ucdenver.edu   
Principal Investigator: Peter Kabos, MD         
US Oncology - Rocky Mountain Cancer Centers - Midtown Recruiting
Denver, Colorado, United States, 80218
Contact: Robert Rifkin    303-418-7639    robert.rifkin@usoncology.com   
Contact: Patrick Moran    +33491223740    patrick.moran@usoncology.com   
Principal Investigator: Sara Robinson         
Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System Recruiting
Fort Collins, Colorado, United States, 80528
Contact: Jill Wood    970-297-6163    jill.wood2@uchealth.org   
Contact: Allison Faltermier    970-237-7777    allison.faltermier@uchealth.org   
Principal Investigator: Diana Medgyesy         
United States, District of Columbia
MedStar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Hiwot Guebre-Xabiher       Hiwot.Guebre-Xabiher@medstar.net   
Contact: Karen Vaughan       karen.f.vaughan@medstar.net   
Principal Investigator: Shruti Tiwari, MD         
United States, Florida
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Jennifer Pelley    321-841-4348    jennifer.pelley@orlandohealth.com   
Principal Investigator: Regan Rostorfer, MD         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Amber Voorhees    813-745-6774    amber.voorhees@moffitt.org   
Principal Investigator: Khong Hung         
United States, Georgia
Piedmont Cancer Institute, P.C. - Oncology Recruiting
Atlanta, Georgia, United States, 30318
Contact: Ann Johnston    678-298-3241    AJohnston@piedmontcancerinstitute.com   
Principal Investigator: Rajni Sinha, MD         
Suburban Hematology-Oncology Associates Recruiting
Lawrenceville, Georgia, United States, 30046
Contact: Jennifer Williams    678-312-1000    jennwilliams@gwinnettmedicalcenter.org   
Principal Investigator: Aldemar Montero, MD         
United States, Illinois
Chicago Association for Research and Education in Science Recruiting
Chicago, Illinois, United States, 60141
Principal Investigator: Rami Haddad         
Rush University Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Brittany Ray    312-942-1537    Brittany_j_ray@rush.edu   
Contact: Chelsea McPeek    312-942-2993    Chelsea_G_McPeek@rush.edu   
Principal Investigator: Melody Cobleigh, MD         
Healthcare Research Network II Recruiting
Tinley Park, Illinois, United States, 60487
Contact: Rosemary Beyer    708-745-9970    1rbeyer@healthcareresearchnetwork.com   
Principal Investigator: Subramanya Rao, MD         
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
Contact: Joey Quesenberry    502-629-2500    Joey.Quesenberry@nortonhealthcare.org   
Principal Investigator: Jeffrey Hargis, MD         
Pikeville Medical Center - Oncology/Hematology Recruiting
Pikeville, Kentucky, United States, 41501
Principal Investigator: Christopher Croot         
United States, Louisiana
Ochsner Cancer Institute Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jessica Rentfrow    504-703-2655    jessica.rentfrow@ochsner.org   
Contact: Socea May    (504) 842-2373    smay@ochsner.org   
Principal Investigator: John Cole, MD         
United States, Maine
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
Contact: Jean Mack    207-303-3424    mackj@newecs.org   
Principal Investigator: Tracey Weisberg, MD         
United States, Maryland
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
Contact: Lisa McConnell    410-332-1200    lmcconnell@mdmercy.com   
Contact: Alexandra Cline       acline@mdmercy.com   
Principal Investigator: David Riseberg, MD         
Maryland Oncology Hematology, Recruiting
Frederick, Maryland, United States, 21702
Contact: John Wallmark    301-424-6231    john.wallmark@usoncology.com   
Contact: Carolyn Hendricks    (301) 897-1503    carolyn.hendricks@usoncology.com   
Principal Investigator: Sadaf Taimur         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Amalia Rivera    617-643-5955    arivera29@mgh.harvard.edu   
Principal Investigator: Aitya Bardia, MD         
Mass General Cancer Center at Newton Wellesley - Oncology Recruiting
Boston, Massachusetts, United States, 02462
Principal Investigator: Aditya Bardia         
Mass General North Shore Cancer Center - Oncology Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Hannah Lyons    978-882-6032    hflyons@mgh.harvard.edu   
Contact: Gayle Calistro       gcalistro@mgh.harvard.edu   
Principal Investigator: Sherry Ratcliff         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Bradley Olsen    313-576-9730    olsenb@karmanos.org   
Contact: Allie VanSlembrouck    313-576-9764    vanslema@karmanos.org   
Principal Investigator: Hadeel Assad         
United States, Minnesota
Minnesota Oncology Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Thomas Ducker    612-884-6300    thomas.ducker@usoncology.com   
Contact: Annette Kuck    +1 (612) 884-6300    annette.kuck@usoncology.com   
Principal Investigator: Michaela Tsai         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jean Jensen    507-538-1115    Jensen.Jean@mayo.edu   
Contact: Mitchell Perrizo    507-284-9104    perrizo.mitchell@mayo.edu   
Principal Investigator: Karthik Giridhar         
United States, Mississippi
Jackson Oncology Associates, PLLC. Recruiting
Jackson, Mississippi, United States, 39202
Contact: Teresa Davis    601-974-5547    tdavis@jacksononcology.com   
Contact: Cortney Powell    601-974-5547    cpowell@jacksononcology.com   
Principal Investigator: Bobby Graham         
United States, New Jersey
Precision Cancer Research Recruiting
Freehold, New Jersey, United States, 07728
Contact: Kim Baird    402-991-8468    kbaird@gucancer.com   
Contact: Mercedes Martillo-Zapata    732-390-7750    mmartillo@regionalcancercare.org   
Principal Investigator: Nandini Ignatius         
Saint Barnabas Medical Center - Cancer Center Recruiting
Livingston, New Jersey, United States, 07039
Contact: Joanne Loeb    973-322-8015    Joanne.Loeb@rwjbh.org   
Principal Investigator: Anna Litvak, MD         
United States, New Mexico
New Mexico Oncology Hematology Consultants - Oncology Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Valerie Tucker    402-991-8468    valeriet@nmohc.com   
Principal Investigator: Pranshu Banal, MD         
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Andrea Yost    505-272-7815    ayost@nmcca.org   
Contact: Karwyn Gustafson    +1 505-925-0380    ksgustafson@salud.unm.edu   
Principal Investigator: Ursa Brown-Glaberman         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Kathy Lora    571-231-4162    KLORA@montefiore.org   
Principal Investigator: Joseph Sparano, MD         
New York University Clinical Cancer Center Recruiting
New York, New York, United States, 10016
Contact: Victor Ty       victor.ty@nyulangone.org   
Contact: Cassandra Light       Cassandra.light@nyulangone.org   
Principal Investigator: Yelena Novik, MD         
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Pushpa Talanki    631-638-0815    pushpa.talanki@stonybrookmedicine.edu   
Contact: Molly Rago    (631) 638-0852    molly.rago2@stonybrookmedicine.edu   
Principal Investigator: Alison Stopeck         
United States, Ohio
Oncology Hematology Care Inc. Recruiting
Cincinnati, Ohio, United States, 45211
Principal Investigator: Suzanne Partridge         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Lauren Hricik    216-844-5176    Lauren.Hricik@UHhospitals.org   
Principal Investigator: Paula Silverman, MD         
Toledo Clinic Cancer Center - Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Jennifer Martinez    419-479-5605 ext 5641    jmartinez@toledoclinic.com   
Principal Investigator: Rex Mowat, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jeanette Phillips    971-262-9041    philljea@ohsu.edu   
Principal Investigator: Zahi Mitri, MD         
United States, Pennsylvania
Pinnacle Health Cancer Institute Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Bridgett West    717-724-6768    bwest@pinnaclehealth.org   
Principal Investigator: Kit Lu, MD         
Paoli Hospital Recruiting
Paoli, Pennsylvania, United States, 19301
Contact: Judith Fannelli    484-565-1637    fanellij@mlhs.org   
Contact: Sharon Steinberg    484-476-2395    SteinbergS@mlhs.org   
Principal Investigator: Paul Gilman         
Abington Hematology Oncology Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
Principal Investigator: Joseph Potz         
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Judith Fannelli    484-565-1637    fanellij@mlhs.org   
Contact: Sharon Steinberg    484-476-2395    steinbergs@mlhs.org   
Principal Investigator: Paul Gilman         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Nakia Proge    901-683-0055 ext 62529    nproge@westclinic.com   
Contact: Candice Mitchell    +1 (901) 260-9289    cmitchell@westclinic.com   
Principal Investigator: Gregory Vidal         
Brig Center For Cancer Care And Survivorship Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Kristi Simcox    865-415-3329    ksimcox@brigcancercare.com   
Principal Investigator: Raymond Brig, MD         
United States, Texas
Texas Oncology - Central Austin Cancer Center Recruiting
Austin, Texas, United States, 78731
Contact: Pamela Garza    512-302-1771    pam.garza@usoncology.com   
Contact: Jerry Fain    512-412-4217    jerry.fain@usoncology.com   
Principal Investigator: debra patt         
TX Oncology Dallas Center Recruiting
Dallas, Texas, United States, 75203
Contact: Debora Jimerson    972-780-3406    debora.jimerson@usoncology.com   
Principal Investigator: Atisha Manhas         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Melissa Johnson    972-566-2648    mjohnson@crsti.org   
Contact: Sarah Lopez    972.566.2321    Sarah.Lopez@usoncology.com   
Principal Investigator: Jay Courtright         
Dallas Presbyterian Hospital - Texas Oncology PA Recruiting
Dallas, Texas, United States, 75231
Contact: Cathy Barter    214-739-4175    catherine.barter@usoncology.com   
Principal Investigator: Kristi McIntyre         
Texas Oncology - Willowbrook Recruiting
Houston, Texas, United States, 77070
Principal Investigator: Henna Malik         
Texas Oncology - Willowbrook Recruiting
Houston, Texas, United States, 77070
Contact: John Thachil    940-692-2042    john.thachil@usoncology.com   
Contact: April McGriff    281-897-1215    april.mcgriff@usoncology.com   
Principal Investigator: Henna Malik         
US Oncology Research-- Investigational Product Center Recruiting
Irving, Texas, United States, 75063
Principal Investigator: Shiela Haffar         
US Oncology Research-- Investigational Product Center Recruiting
Irving, Texas, United States, 75063
Principal Investigator: Karen Tedesco         
Texas Oncology - McAllen Recruiting
McAllen, Texas, United States, 78053
Contact: Joseph Litam    956-687-1115    joseph.litam@usoncology.com   
Contact: Billie Marek    956-992-0219    billie.marek@usoncology.com   
Principal Investigator: Alvaro Restrepo         
Texas Oncology, P.A. Recruiting
Paris, Texas, United States, 75460
Contact: Sue Crumpler    903-785-0031    sue.crumpler@usoncology.com   
Principal Investigator: Sucharu Prakash         
Texas Oncology - North Texas Regional Cancer Center Recruiting
Plano, Texas, United States, 75075
Principal Investigator: Christopher Stokoe         
Texas Oncology, P.A. Recruiting
Plano, Texas, United States, 75093
Contact: Jaime Roman    972-596-7801    jaime.roman@usoncology.com   
Contact: Andrew Kovoor    972-596-7801    andrew.kovoor@usoncology.com   
Principal Investigator: Philip Kovoor         
Cancer Therapy and Research Center at UTHSCSA Recruiting
San Antonio, Texas, United States, 78229
Contact: Maggie Tomasini    210-450-5882    tomasinim@uthscsa.edu   
Principal Investigator: Virginia Kaklamani, MD         
Texas Oncology - The Woodlands, Gynecologic Oncology Recruiting
The Woodlands, Texas, United States, 77380
Principal Investigator: Paula Ryan         
Renovatio Clinical Recruiting
The Woodlands, Texas, United States, 77389
Contact: Gambo Dangwaran    713-703-2398    gambo.dangwaran@renovatioclinical.com   
Contact: Naim Andrea    +1 713-703-2398    naim.andrea@renovatioclinical.com   
Principal Investigator: Mary Crow         
USO Texas Oncology - Tyler Recruiting
Tyler, Texas, United States, 75702
Principal Investigator: Sasha Strain         
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84124
Contact: Jesse Whitfield    801-270-2258    jwhitfield@utahcancer.com   
Principal Investigator: Kendall Stephen, MD         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jacob Boyd    434-243-0425    jlb2nw@hscmail.mcc.virginia.edu   
Principal Investigator: Patrick Dillon, MD         
Inova Schar Cancer Institute Recruiting
Fairfax, Virginia, United States, 22031
Contact: Kelly Peterson    571-720-5210    kelly.peterson@inova.org   
Principal Investigator: Kathleen Harnden, MD         
Fort Belvoir Community Hospital Recruiting
Fort Belvoir, Virginia, United States, 22060
Contact: Allison Mentzos    571-231-4162    allison.e.mentzos.ctr@mail.mil   
Principal Investigator: Pramvir Verma         
United States, Washington
Benaroya Research Institute at Virginia Mason Recruiting
Seattle, Washington, United States, 98101
Principal Investigator: Meaghan O'Malley         
Argentina
Centro Médico Austral Recruiting
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, 1019
Contact: tamara romero    +54 11 4811 0941    tamara.romero@centromedicoaustral.com.ar   
Principal Investigator: Guillermo Streich         
Hospital Britanico de Buenos Aires Recruiting
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina, C1280AEB
Principal Investigator: Ernesto Korbenfeld         
Centro para la Atención Integral del paciente Oncológico Recruiting
San Miguel de Tucumán, Tucumán, Argentina, T4000GTB
Contact: Celina Garcia    0054 0381 4215 825    celugarcia@yahoo.com.ar   
Contact: Cecilia Karbiner    5493815624841    mc_k07@hotmail.com   
Principal Investigator: Felipe Palazzo         
Fundacion CENIT para la Investigación en Neurociencias - Clinic Recruiting
Ciudad Autonoma de Buenos Aire, Argentina, C1025ABI
Contact: Carla Mendoza    54 11 59955296    carlacarina.mendoza@gmail.com   
Principal Investigator: Guillermo Lerzo         
Clínica Universitaria Reina Fabiola Recruiting
Córdoba, Argentina, 5004
Principal Investigator: Santiago Rafael Bella         
Fundación CORI Recruiting
La Rioja, Argentina, 5300
Contact: Brenda De La Vega    +54 380 4468748    ba.dlvega@hotmail.com   
Contact: Romina Paredes    +54 380 4468748    rnparedes@outlook.com   
Principal Investigator: Diego Kaen         
Fundación CORI Recruiting
La Rioja, Argentina, 5300
Contact: Brenda De La Vega    +54 380 4468748    ba.dlvega@hotmail.com   
Contact: Romina Paredes    543804468748    rnparedes@outlook.com   
Principal Investigator: Diego Kaen         
Sanatorio de la Mujer Recruiting
Rosario, Argentina, 2000
Contact: Dana Carboné    54 0341 449 8880/8    danaacarbone@gmail.com   
Principal Investigator: Cristina Nasurdi         
Australia
Sunshine Coast University Hospital Recruiting
Birtinya, Australia, 4575
Contact: Christine Cocks    +61 7 5202 0651    christine.cocks@health.qld.gov.au   
Contact: Christelle Catuogno    07 5202 0652    christelle.catuogno@health.qld.gov.au   
Principal Investigator: Michelle Morris         
Macarthur Cancer Therapy Recruiting
Campbelltown, Australia, 2560
Contact: Suma Santhosh    +61 (0) 2 46344370    suma.santhosh@sswahs.nsw.gov.au   
Contact: Melissa Fox    61 2 46344343    melissa.fox1@health.nsw.gov.au   
Principal Investigator: Belinda Kiely         
St Vincent's Hospital Melbourne Recruiting
Fitzroy, Australia, 3065
Contact: Nadia Ranieri    613 9288 3167    nadia.ranieri@svhm.org.au   
Contact: Jacqueline Duval    61 (3) 9231 3174    jacqueline.duval@svha.org.au   
Principal Investigator: Melissa Moore         
Austria
Klinikum Wels-Grieskirchen GmbH Recruiting
Wels, Oberösterreich, Austria, 4600
Contact: Katharina Schmied    +43 7242 415 3452    Katharina.Schmied@klinikum-wegr.at   
Contact: Teresa Bogensperger    +43 7242 415-3452    teresa.bogensperger@klinikum-wegr.at   
Principal Investigator: Corinna Netolitzky         
Landeskrankenhaus (LKH) Leoben-Eisenerz Recruiting
Leoben, Steiermark, Austria, 8700
Contact: Theresia Egger    +43 3842 401 3405    Theresia.Egger@kages.at   
Contact: Kathrin Heinrich    +43 3842 401 3405    kathrin.heinrich@kages.at   
Principal Investigator: Florentia Peintinger         
Universitätsklinik Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Carmen Albertini    +43 512 504 82477    carmen.albertini@tirol-kliniken.at   
Contact: Johannes Eder    +43 512 504 82477    michael.hubalek@i-med.ac.at   
Principal Investigator: Daniel Egle         
Belgium
AZ Klina Recruiting
Brasschaat, Antwerpen, Belgium, 2930
Contact: Sofie Herman    +3236505277    sofie.herman@klina.be   
Contact: Gwen Colfs    +3236505273    gwen.colfs@klina.be   
Principal Investigator: Didier Verhoeven         
UZ Antwerpen - Oncologie Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Peggy De Clercq    +32 3 821 53 07    Peggy.DeClercq@uza.be   
Contact: Amélie Lyssens    + 32 3 821 55 80    amelie.lyssens@uza.be   
Principal Investigator: Wiebren Tjalma         
AZ Turnhout Recruiting
Turnhout, Antwerpen, Belgium, 2300
Contact: Nel Bovin    +32 14 40 69 08    nel.bovin@azturnhout.be   
Contact: Sarah Geentjens    +32 14 40 69 12    Sarah.Geentjens@azturnhout.be   
Principal Investigator: Jean Meyskens         
Institut Jules Bordet - Oncologie Médicale Recruiting
Brussels, Brussels Capital Region, Belgium, 1000
Contact: Berline Tako    0032 2 541 32 28    berline.takomouafo@bordet.be   
Contact: Gaëlle Metz    0032 2 541 72 51    gaelle.metz@bordet.be   
Principal Investigator: Philippe Aftimos         
UZ Brussel - Campus Jette Recruiting
Brussel, Brussels Capital Region, Belgium, 1090
Contact: Alex Dewaele    +32 2 477 60 45    alex.dewaele@uzbrussel.be   
Contact: Gerda Lauwers    +3224775448    gerda.lauwers@uzbrussel.be   
Principal Investigator: Christel Fontaine         
CHU Brugmann Recruiting
Bruxelles, Brussels Capital Region, Belgium, 1020
Contact: Baptiste Dumoulin    32-2-477-33-13    baptiste.dumoulin@chu-brugmann.be   
Contact: Muriel Moriau    +32 2 477 37 29    muriel.moriau@chu-brugmann.be   
Principal Investigator: Catherine Vansteelandt         
Cliniques Universitaires Saint-Luc - Oncology Recruiting
Bruxelles, Brussels Capital Region, Belgium, 1200
Contact: Nathalie Study Coordinator    32 2 764 42 14    nathalie.blondeel@uclouvain.be   
Contact: Elodie Villar    +32 2 764 42 14    elodie.villar@uclouvain.be   
Principal Investigator: Francois Duhoux         
Grand Hôpital de Charleroi - Site Notre-Dame Recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Janique Dewelle    +3271104709    janique.dewelle@ghdc.be   
Contact: Stéphanie Adam    +32 71 10 47 62    stephanie.adam@ghdc.be   
Principal Investigator: Jean-Luc Canon         
INDC Entité Jolimontoise - CH de Jolimont-Lobbes Recruiting
Haine-Saint-Paul, Hainaut, Belgium, 7100
Contact: Thecle Fourneaux    +3264234662    thecle.fourneaux@jolimont.be   
Contact: Isabelle Buelens    +32 64 23 18 04    isabelle.buelens@jolimont.be   
Principal Investigator: Caterina Confente         
Centre Hospitalier de l'Ardenne - Site de Libramont Recruiting
Libramont, Luxembourg, Belgium, 6800
Contact: Céline Louis    +3261622683    celine.louis@vivalia.be   
Contact: Oumhani Meftahi    +3261622683    oumhani.meftahi@vivalia.be   
Principal Investigator: Frédéric Forget         
Onze-Lieve-Vrouwziekenhuis Aalst Recruiting
Aalst, Oost-Vlaanderen, Belgium, 9300
Contact: Ilse Claessens    32-53-72-45-02    ilse.claessens@olvz-aalst.be   
Contact: Hilde Keymeulen    32-53-72-41-60    hilde.keymeulen@olvz-aalst.be   
Principal Investigator: Adelheid Roelstraete         
AZ Nikolaas - Campus Sint-Niklaas Moerland Recruiting
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Contact: Goele Wallays    +32 3 760 25 73    goele.wallays@aznikolaas.be   
Contact: Emily Van Gucht    3237602975    emily.vangucht@aznikolaas.be   
Principal Investigator: Ines Deleu         
Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Joke De Roover    +32 16 34 74 19    joke.deroover@uzleuven.be   
Contact: Daisy Supply    +32 16 34 75 87    daisy.supply@uzleuven.be   
Principal Investigator: Patrick Neven         
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Contact: Els Van Oyen    +32 50 45 25 54    els.vanoyen@azsintjan.be   
Contact: Angelique Slock    +3250452849    Angelique.Slock@azsintjan.be   
Principal Investigator: Eveline De Cuypere         
AZ Groeninge Recruiting
Kortrijk, West-Vlaanderen, Belgium, 8500
Contact: Ellen Callens    +32 56 63 39 43    ellen.callens@azgroeninge.be   
Contact: Charlotte Vankeirsbilck    +32 56 63 39 42    Charlotte.vankeirsbilck@azgroeninge.be   
Principal Investigator: Laure Nuytemans         
AZ Groeninge - Campus Kennedylaan Recruiting
Kortrijk, Belgium, 8500
Contact: Ellen Callens    +32 56 63 39 43    ellen.callens@azgroeninge.be   
Contact: Charlotte Vankeirsbilck    +32 56 63 39 42    charlotte.vankeirsbilck@azgroeninge.be   
Principal Investigator: Marleen Borms         
CHU UCL Namur - Site Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Caroline Yague    32 81 702 843    caroline.yague@cmsenamur.be   
Contact: Monique Gilsoul    monique.gilsoul@cmsenamur.be    monique.gilsoul@cmsenamur.be   
Principal Investigator: Peter Vuylsteke         
CHU UCL Namur Campus Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Caroline Yague    32 81 702 843    caroline.yague@cmsenamur.be   
Contact: Monique Gilsoul    +32 81 72 05 48    monique.gilsoul@cmsenamur.be   
Principal Investigator: Peter Vuylsteke         
Principal Investigator: Donatienne Taylor         
Clinique Saint Pierre Recruiting
Ottignies, Belgium, 1340
Contact: Martine Gerard    +3210437194    martine.gerard@cspo.be   
Contact: Isabelle Vanbellinghen    +3210437648    isabelle.vanbellinghen@cspo.be   
Principal Investigator: Renaud Poncin         
Canada, Quebec
Pharmacie du CRCHUM Recruiting
Montreal, Quebec, Canada, H2X 1R9
Contact: Lydia Tkalec    514-890-8000 ext 14186    lydia.tkalec.chum@ssss.gouv.qc.ca   
Principal Investigator: Danielle Charpentier         
McGill University Health Centre - Cedars Cancer Center - Oncology Recruiting
Montreal, Quebec, Canada, H4A-3J1
Contact: Stelliana Moreno    +1514 934 1934 ext 43130    stelliana.moreno@muhc.mcgill.ca   
Contact: Amanda Tanti    +1514 934 1934    amanda.tanti@muhc.mcgill.ca   
Principal Investigator: Michael Thirlwell         
Canada
CHU de Quebec - Hopital du Saint Sacrement Recruiting
Québec, Canada, G1S 4L8
Contact: Judith-Elise Marcoux    1-418-525-4444 ext 84577    judith-elise.marcoux@chudequebec.ca   
Contact: Isabelle Ouellet    (418)-682-7511 ext 84553    isabelle.ouellet.cha@ssss.gouv.qc.ca   
Principal Investigator: Dominique Boudreau         
Denmark
Vejle Sygehus Recruiting
Vejle, South Denmark, Denmark, 7100
Contact: Gitte Møller    +4579406709    gitte.eiberg.moeller@rsyd.dk   
Contact: Annette Rehmeier    +4579406042    annette.rehmeier@rsyd.dk   
Principal Investigator: Erik Jakobsen         
Næstved Sygehus Recruiting
Næstved, Zeeland, Denmark, 4700
Contact: Ellen Røge    +45 5651 3227    emr@regionsjaelland.dk   
Contact: Lars Larsen    +45 5651 3917    laml@regionsjaelland.dk   
Principal Investigator: Vesna Glavicic         
Aalborg Universitetshospital Recruiting
Aalborg, Denmark, 9100
Contact: Mette Meyer    +45 97661291    mem@rn.dk   
Principal Investigator: Támas Lörincz         
Odense Universitetshospital - Oncology Recruiting
Odense, Denmark, 5000
Contact: Lene Sandberg    +4521350492    Lene.Sandberg@rsyd.dk   
Contact: Luise Bonde    +45 2360 4925    luise.kvist.bonde@rsyd.dk   
Principal Investigator: Jeanette Jensen         
France
Centre de Lutte Contre le Cancer (CLCC) Recruiting
Caen, Calvados, France, 14076
Contact: Sara Grossi    +33 2 31 45 50 99    grosa@baclesse.unicancer.fr   
Contact: Boly ANN    +33 (0)2 31 45 50 02 ext 51-04    b.ann@baclesse.unicancer.fr   
Principal Investigator: Christelle LEVY         
Hopital Trousseau - Service d'oncologie médicale Recruiting
Tours, Indre-et-Loire, France, 37044
Contact: Delphine Braconnier    +33 2 47 47 80 75    delphine.braconnier@univ-tours.fr   
Contact: Celine OLIVEAU    02 47 47 47 47    c.oliveau@chu-tours.fr   
Principal Investigator: Hélène Vegas         
Centre Jean Perrin Recruiting
Clermont Ferrand, Puy-de-Dôme, France, 63011
Contact: Marie Reymond    +33 (0)4 73 27 84 54    marie.reymond@clermont.unicancer.fr   
Contact: Alexia Giro    33 (0)3.80.73.75.00    alexia.giro@clermont.unicancer.fr   
Principal Investigator: Marie-Ange Mouret-Reynier         
Centre François Baclesse Service Pharmacie Recruiting
Caen, France, 14076
Contact: Sara Grossi    +33 2 31 45 50 99    grosa@baclesse.unicancer.fr   
Contact: Boly ANN    +33 (0)2 31 45 50 02 ext 51-04    b.ann@baclesse.unicancer.fr   
Principal Investigator: Christine Levy         
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Céline Goulas    33380737756    cgoulas@cgfl.fr   
Principal Investigator: Audrey Hennequin         
Hôpital Privé Jean Mermoz Département Pharmacie Recruiting
Lyon, France, 69008
Contact: Gaëlle LE GULUDEC    +33 4 37 53 87 64    g.leguludec@ramsaygds.fr   
Contact: Stéphanie GIRODET    + 33 4 37 53 87 02    s.girodet@ramsaygds.fr   
Principal Investigator: OLFA DERBEL         
"Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques" Recruiting
Montpellier, France, 34298
Contact: Mélanie BEAUJOUIN    +33 4 67 61 25 15    melanie.beaujouin@icm.unicancer.fr   
Principal Investigator: Séverine GUIU         
Centre De Lutte Contre Le Cancer - Institut Curie - Département d'Oncologie Médica Recruiting
Paris, France, 75005
Contact: Julie MEURISSE    +33 1 56 245 640    julie.meurisse@curie.fr   
Principal Investigator: Francois-Clement Bidard         
Hôpital René Huguenin - Institut Curie - Oncologie médicale Recruiting
Saint-Cloud, France, 92210
Contact: Stephanie Dupont-Casquin    +33 1 47 11 18 53    stephanie.dupont-casquin@curie.fr   
Contact: Ouarda IBEGAZENE    +33 (0)1 47 11 23 73    ouarda.ibegazene@curie.fr   
Principal Investigator: Francois-Clement Bidard         
"Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques" Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Pauline FAVRE    04 77 91 74 84    pauline.favre@icloire.fr   
Contact: Lucie SUC    0477917470    lucie.suc@icloire.fr   
Principal Investigator: Jean-Philippe Jacquin         
IUCT-Oncopole Pharmacie-Essais Cliniques Recruiting
Toulouse, France, 31100
Contact: Lilia BOUADJERA    (+33)5 31 15 58 15    Bouadjera.Lilia@iuct-oncopole.fr   
Principal Investigator: Florence Dalenc         
Greece
University General Hospital Of Patras - Dpt Of Medicine, Division Oncology Recruiting
Patra, Achaïa, Greece, 26504
Contact: Eleni Mouzaki    +302610999781    muzaki@otenet.gr   
Principal Investigator: Haralabos Kalofonos         
Metropolitan Hospital - Oncology Unit Recruiting
Athens, Attiki, Greece, 18547
Contact: Kanella-Maria Gkiatis    +306979920006    ongologiki1@metropolitan-hospital.gr   
Principal Investigator: Helena Linardou         
University General Hospital of Larissa Recruiting
Larissa, Larisa, Greece, 41110
Contact: Athanasia Dalgiannaki    00302413502027    adalgiannaki@gmail.com   
Contact: Rafaella-Eirini Karageorgou    00302413502124    rafkmed@yahoo.com   
Principal Investigator: Athanasios Kotsakis         
Bioclinic Thessaloniki Recruiting
Thessaloniki, Greece, 54622
Contact: Panagiota Papadopoulou    00302310372699    giota0806@gmail.com   
Principal Investigator: Ioannis Boukovinas         
Hungary
Pécsi Tudományegyetem Klinikai Központ Recruiting
Pécs, Baranya, Hungary, 7623
Contact: Andrea Szatyor-Jarkovich    +3672536001/33505    andrea.jarkovich@coordination.hu   
Principal Investigator: László Mangel         
Bács-Kiskun Megyei Kórház Recruiting
Debrecen, Hajdú-Bihar, Hungary, 4032
Contact: Zoltánné Talladi    +3652255840    talladine@freemail.hu   
Contact: Tünde Furka    +36 20 526 3262    furka.tunde@med.unideb.hu   
Principal Investigator: Judit Kocsis         
Debreceni Egyetem Klinikai Központ Recruiting
Debrecen, Hajdú-Bihar, Hungary, 7032
Contact: Angela Toth    +3652255840    toth.angela@med.unideb.hu   
Contact: Agnes GYURO    +3652538001    gyuroagi@gmail.com   
Principal Investigator: Peter Arkosy         
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint Recruiting
Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
Contact: Edina Bodor    36204437248    edina.bodor11@gmail.com   
Principal Investigator: Tibor Csoszi         
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór Recruiting
Nyiregyhaza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Contact: Katalin Korodine Karaszi    +3642599700 / 1004    korodine.karaszi.katalin@szszbmk.hu   
Principal Investigator: Klara Mezei         
Uzsoki Utcai Kórház Recruiting
Budapest, Hungary, 1145
Contact: Tamás Hangyál    +36-20-932-2519    tamas.hangyal@coordination.hu   
Contact: Vanda Filep    +36202949939    vanda.filep@coordination.hu   
Principal Investigator: Laszlo Landherr         
Semmelweis Egyetem, Onkológiai Központ, Recruiting
Budapest, Hungary, H-1083
Contact: Brigitta Meszaros    +36 (1) 459-1500    trial.sote@gmail.com   
Principal Investigator: Magdolna Dank         
Országos Onkológiai Intézet Recruiting
Budapest, Hungary, H-1122
Contact: Alexandra Hajdú    3612248763    alexandra.hajdu@coordination.hu   
Contact: Brigitta Balogh    36209322286    brigitta.balogh@coordination.hu   
Principal Investigator: Gabor Rubovszky         
Ireland
Bon Secours Hospital [Oncology] Recruiting
Cork City, Ireland
Contact: Aoife O' Shea    00353 21 454 2807 Ext: 2663    aoshea@bonsecours.ie   
Principal Investigator: Conleth Murphy         
Cork University Hospital Recruiting
Cork, Ireland, T12 DC4A
Principal Investigator: Seamus O'Reilly         
Aseptic Compounding/Carney Unit, Lvl7 Whitty Bldg, Mater Misericordiae Univ Hosp Recruiting
Dublin, Ireland, D07 R2WY
Principal Investigator: Catherine M. Kelly         
Haematology Oncology Daycare (HODC) St James's Hospital Recruiting
Dublin, Ireland
Contact: April Spollen    +353 (0)1 4284935    aspollen@stjames.ie   
Principal Investigator: Michael Kennedy         
St Vincent's University Hospital Recruiting
Dublin, Ireland
Contact: Naoise Kelly    35301 221 4839    naoise.kelly@ccrt.ie   
Principal Investigator: Janice Walshe         
Clinical Research Facility, St. James's Hospital Recruiting
Sligo, Ireland, F91 H684
Contact: April Spollen    +353 (0)1 4284935    aspollen@stjames.ie   
Principal Investigator: Michael Kennedy         
Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital Recruiting
Sligo, Ireland, F91 H684
Contact: Asma Patel    0877954251    asmanisar@gmail.com   
Principal Investigator: Michael John Martin         
Sligo University Hospital Recruiting
Sligo, Ireland, F91 H684
Contact: Michael John Martin       michaelj.martin@hse.ie   
Contact: 353-71-917-4693         
Principal Investigator: Michael John Martin         
Pharmacy, UHW Recruiting
Waterford, Ireland, X91 ER8E
Contact: Elaine Shanahan    +353 (51) 848934    elaines.shanahan@hse.ie   
Principal Investigator: Miriam O Connor         
Israel
Assaf Harofeh Medical Center Recruiting
Be'er Ya'aqov, HaDarom, Israel, 7030000
Contact: Sharona Ben-Ami    972-8-9778003    sharonab@asaf.health.gov.il   
Contact: Yael Yaniv    +97289779999    yaely@asaf.health.gov.il   
Principal Investigator: Arnold Cyjon         
Principal Investigator: Daniela Katz         
Shaare Zedek Medical center Recruiting
Jerusalem, Israel, 9103102
Contact: Yair Plesser    +97226555727    yairp@szmc.org.il   
Contact: Dalia Sherizen    +972-2-6555424    daliash@szmc.org.il   
Principal Investigator: Shani Paluch-Shimon         
Hadassah MO - Oncology,Hadassah MO Recruiting
Jerusalem, Israel, 9112001
Contact: Hen Handrus    +972-50-3522422    henha@hadassah.org.il   
Contact: Inbal Fuchs    +972-50-2134312    inbalf@hadassah.org.il   
Principal Investigator: Tamar Peretz-Yablonski         
Meir Medical Center Recruiting
Kfar-Saba, Israel, 4428164
Contact: Galit Gordin    972-9-7472337    galit.gordin@clalit.org.il   
Contact: Noa Rapaport    972-9-7472695    noa.rapoport@clalit.org.il   
Principal Investigator: Iryna Kuchuk         
Galilee Medical Center Recruiting
Nahariya, Israel, 2210001
Contact: Reut Peled    97249107365    reutp@gmc.gov.il   
Principal Investigator: Ayelet Shai         
Rabin Medical Center - Beilinson Hospital - Davidoff Cancer Recruiting
Petah Tikva, Israel, 4941492
Contact: Lital Frangi    +97239378076    litalf@clalit.org.il   
Contact: Adva Reches    9723-9378089    advare@clalit.org.il   
Principal Investigator: Rinat Yerushalmi         
Tel Aviv Sourasky Medical Center - Oncology Recruiting
Tel-Aviv, Israel, 6423906
Contact: Hana Maik-Notea    +97236947615    hanamn@tlvmc.gov.il   
Contact: Hagit Damchiner-Pearl    +97236973082    hagitdp@tlvmc.gov.il   
Principal Investigator: Ido Wolf         
Principal Investigator: Amir Sonnenblick         
The Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 5265601
Contact: Meirav Gelibter    972-3-5307633    Meirav.Gelibter@sheba.health.gov.il   
Contact: Limor Peretz    +972-3-5307035    limor.peretz@sheba.health.gov.il   
Principal Investigator: Bella Kaufman         
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 7030000
Contact: Sharona Ben-Ami    972-8-9778003    sharonab@asaf.health.gov.il   
Contact: Milena Vugman    972-8-9542103    milenav@shamir.gov.il   
Principal Investigator: Daniela Katz         
Italy
Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni Recruiting
Bologna, Italy, 40138
Contact: Cinzia Pizzirani    +390512144547    cinzia.pizzirani@aosp.bo.it   
Contact: Maria Pagliaro    +390516364547    maria.pagliaro@aosp.bo.it   
Principal Investigator: Claudio Zamagni         
PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona Recruiting
Cremona, Italy, 26100
Contact: Martina Dester    +390372408374    destermartina@gmail.com   
Principal Investigator: Daniele Generali         
DiMI, Dipartimento di Medicina interna e Specialità mediche, Recruiting
Genova, Italy, 16132
Contact: Maurizio Gallo    +390103538940    maurizio.gallo@unige.it   
Contact: Daniela Garbarino    +39 0103538940    daniela.garbarino@dimi.unige.it   
Principal Investigator: Alberto Ballestrero         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Recruiting
Meldola, Italy, 47014
Contact: Francesca Mannozzi    0543739444    francesca.mannozzi@irst.emr.it   
Principal Investigator: Andrea Rocca         
Azienda Ospedaliero-Universitaria Policlinico di Modena Recruiting
Modena, Italy, 41100
Contact: Federica Caggìa    +390594223134    federica.caggia@unimore.it   
Principal Investigator: Laura Cortesi         
Ospedale San Gerardo-ASST Monza Recruiting
Monza, Italy, 20900
Contact: Stefania PEDROLI    +39 0392334514    pedroli.datamanager.monza@gmail.com   
Principal Investigator: Marina Cazzaniga         
AOU Maggiore della Carità - SC Oncologia Recruiting
Novara, Italy, 28100
Contact: Stefania Cresta    +39 0321 3733644    stefania.cresta@maggioreosp.novara.it   
Contact: Paola Maggiora    (+39) 0321.373-2148    paolamaria.maggiora@maggioreosp.novara.it   
Principal Investigator: Alessandra Gennari         
Azienda Ospedaliero-Universitaria di Parma Recruiting
Parma, Italy, 43126
Contact: Roberta Camisa    +39-0521-702682    rcamisa@ao.pr.it   
Contact: Elena Rapacchi    +39 0521702682    erapacchi@ao.pr.it   
Principal Investigator: Antonino Musolino         
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Alessandra Ferrari    0039 0382503689    alessandra.ferrari@smatteo.pv.it   
Contact: Daniela Cicognini    0039 0382-502511    d.cicognini@smatteo.pv.it   
Principal Investigator: Elisa Ferraris         
SO S.Chiara, AOU Pisana - Oncologia 2 Recruiting
Pisa, Italy, 56126
Contact: Cinzia Orlandini    +39 050992466    c.orlandini@med.unipi.it   
Contact: Maria Bianco    0039 050993173    mg.bianco@ao-pisa.toscana.it   
Principal Investigator: Andrea Fontana         
Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma, Recruiting
Roma, Italy, 00128
Contact: Cinzia Potestà    +39 06225411160    c.potesta@unicampus.it   
Contact: Teresa Grassani    +39 06225411160    t.grassani@unicampus.it   
Principal Investigator: Giuseppe Tonini         
Policlinico A. Gemelli Recruiting
Roma, Italy, 00168
Contact: Celeste Pirozzoli    +39 06 30155202    celestepirozzoli@yahoo.it   
Contact: Maria Teberino    +39 06 3015202    oncomedsperimentali@policlinicogemelli.it   
Principal Investigator: Emilio Bria         
Azienda Sanitaria Universitaria Integrata di Udine Recruiting
Udine, Italy, 33100
Contact: Roberta Sottile    +390432559330    sottile.roberta@aoud.sanita.fvg.it   
Contact: Enrica Epifani    0039 0382-502511    e.epifani@smatteo.pv.it   
Principal Investigator: Mauro Mansutti         
Korea, Republic of
National Cancer Center Recruiting
Goyang, Korea, Republic of, 10408
Contact: Sukhee 숙희 Lim 임    +82-31-920-0416    pposuki@ncc.re.kr   
Contact: Jeong-A 정아 Park 박    82-31-920-0441    p1209s@ncc.re.kr   
Principal Investigator: Sim 심 Sung Honn 성훈         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Contact: So Hee 소희 Choi 최    +82 32-460-3231    hihi7739@naver.com   
Contact: Young Shin 영신 Lim 임    +82-32-460-3231    youngsshin77@naver.com   
Principal Investigator: Hee Kyung Ahn         
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of, 13620
Contact: Jaehee 재희 Kim 김    82-31-787-8224    r2174@snubh.org   
Contact: Seongwon 성원 Yoon 윤    82 31-787-8226    r2460@snubh.org   
Principal Investigator: Jee hyun Kim         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Yuhyun 유현 Kim 김    82 2 920 6089    yuhyun910@naver.com   
Principal Investigator: Kyong Haw Park         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Yun hee 윤희 Choi 최    +82-2-6072-5172    hoihero@hanmail.net   
Contact: Mie soon 미순 In 인    +82-2-2072-0795    inmisoon@daum.net   
Principal Investigator: Seock-ah Im         
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Contact: HwaYoung 화영 Lee 이    82-2-2228-8173    jhlee12@yuhs.ac   
Contact: YangSoon 양순 Kim 김    82-2-2228-8173    bangyh@yuhs.ac   
Principal Investigator: Joo Hyuk Sohn         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Yuri 유리 Son 손    +82-2-3010-6096    9830625s@hanmail.net   
Contact: Jung Eun 정은 Hwang 황    +82-2-3010-5602    hje7017@naver.com   
Principal Investigator: Kyung Hae Jung         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Inkyung 인경 Jung 정    +82-2-3410-6488    ik.jung@samsung.com   
Contact: SeonA 선아 Jang 장    +82234101254    seona.jang@samsung.com   
Principal Investigator: Yeon Hee Park         
Portugal
Instituto Português de Oncologia de Coimbra Recruiting
Coimbra, Portugal, 3000-075
Contact: Teresa Carvalho    +351963330975    tmpct3@gmail.com   
Contact: Gabriela Sousa    +351963330975    gssousa3140@gmail.com   
Principal Investigator: Mónica Mariano         
Hospital Senhora da Oliveira - Guimarães, E.P.E. Recruiting
Guimarães, Portugal, 4835-044
Contact: Joana Vale    +351910120513    jvale@blueclinical.pt   
Contact: Joana Freitas    351910120513    jfreitas@blueclinical.pt   
Principal Investigator: Alexandra Texeira         
Hospital da Luz Recruiting
Lisboa, Portugal, 1500-650
Contact: Monica Nave    +351217104400    mnave@hospitaldaluz.pt   
Contact: Filipa Nunes    +351217104400    filipa.nunes@hospitaldaluz.pt   
Principal Investigator: Monica Nave         
Instituto Português Oncologia Francisco Gentil do Porto Recruiting
Porto, Portugal, 4200-072
Contact: Ana Finisterra    +351225084000    ana.finisterra@ipoporto.min-saude.pt   
Principal Investigator: Susana Sousa         
Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03202
Contact: Rosa Perea Fernández    +34966616250    perearos@gmail.com   
Contact: Federico Menárguez    966 616 250    f.carlosmenarguez@gmail.com   
Principal Investigator: Alvaro Rodríguez Lescure         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Andalucía, Spain, 41013
Contact: Mª Ángeles Oyarzabal Cespedes    +34 955 013 068    oyarzabalma@hotmail.com   
Contact: Laura Bernal Iriarte    +34-671 533 374    ensayosclinicos.hvr.sspa@juntadeandalucia.es   
Principal Investigator: Manuel Ruiz Borrego         
Hospital Universitario de Canarias Recruiting
Tenerife, Canarias, Spain, 38320
Contact: Rita Alonso    +34 922678204    mariaalonsohuc@hotmail.com   
Contact: Lorena González    +34922678745    lorenagbhuc@hotmail.com   
Principal Investigator: Jose Batista         
Hospital de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Teresa Prieto Leache    848.42.15.54    teresa.prieto.leache@navarra.es   
Principal Investigator: José Illarramendi         
Hospital Xeral Álvaro Cunqueiro Recruiting
Vigo, Pontevedra, Spain, 36312
Contact: Alfredo Rodriguez    0034 986 81 60 00    fredysuko@hotmail.com   
Contact: Maria Rodríguez Rodríguez    +34 98 6825830    maria.rodriguez@iisgaliciasur.es   
Principal Investigator: Isabel Lorenzo Lorenzo         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Montserrat Fontanillas Isern    +34 93 227 54 00/54 02    mfontani@clinic.ub.es   
Principal Investigator: Montserra Muñoz Mateu         
IOB Ruber Internacional Recruiting
Madrid, Spain, 28034
Contact: Sara Lavin Sanchez    91 387 50 90/91    sara.lavin@iob-onco.com   
Contact: Natalia Polo    +34 91 336 8263    natalia.polo@iob-onco.com   
Principal Investigator: Javier Cortés Castán         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: María del Alfonso    + 34913303000, ext. 7545    mariadelrosario.alfonso@salud.madrid.org   
Contact: Belén Cobaleda    0034913303000 Ext:7526    belencobaleda.hcsc@gmail.com   
Principal Investigator: José García Sáenz         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Susana Feliu    +34 91 727 7000    susana.ft@hotmail.com   
Principal Investigator: Pilar Zamora Auñón         
Hospital Universitario Virgen de la Macarena Recruiting
Sevilla, Spain, 41009
Contact: Maria Sánchez    0034 671592620    mluisasleon@gmail.com   
Principal Investigator: Luis de la Cruz Merino         
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Isabel Catoira    +3496362 22 38    catoira_isa@gva.es   
Principal Investigator: Begoña Bermejo de las Heras         
United Kingdom
Velindre Cancer Centre - Oncology Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Clare Boobier    +442920316986    clare.boobier@wales.nhs.uk   
Contact: Anila Parveen    +44 02920 615888    anila.parveen@wales.nhs.uk   
Principal Investigator: Simon Waters         
University College London Hospitals Recruiting
London, United Kingdom, NW1 2PG
Contact: Sam Morris    00442034478817    sam.morris@uclh.nhs.uk   
Contact: Connor McAlpine       connor.mcalpine@nhs.net   
Principal Investigator: Fharat Raja         
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
Contact: Thomas (Tom) Davies    442032195200    thomas.davies@hcahealthcare.co.uk   
Principal Investigator: Carmen Murias Henriquez         
Taunton and Somerset NHS Trust Recruiting
Taunton, United Kingdom, TA1 5DA
Contact: John Graham    +441823 343527    john.graham@nhs.net   
Principal Investigator: Saiqa Spensley         
Royal Cornwall Hospital (RCH) - Sunrise Centre Recruiting
Truro, United Kingdom, TR1 3LJ
Contact: Alyson Andrew    4401872 256423    alyson.andrew@nhs.net   
Principal Investigator: Duncan Wheatley         
Sponsors and Collaborators
Radius Pharmaceuticals, Inc.
Investigators
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Study Director: Sr. Director, Clinical Operations Radius Health, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03778931    
Other Study ID Numbers: RAD1901-308
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Fulvestrant
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Receptor Antagonists