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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 18, 2018
Last Update Posted : November 8, 2019
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 : November 20, 2018
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

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Locations
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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         
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         
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         
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         
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         
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, PC - Lawrenceville Recruiting
Lawrenceville, Georgia, United States, 30046
Contact: Jennifer Williams    678-312-1000    jennwilliams@gwinnettmedicalcenter.org   
Principal Investigator: Aldemar Montero, 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
Cancer Care Specialists of Central Illinois, S.C. (CCSCI) - Cancer Care Center of Decatur Recruiting
Decatur, Illinois, United States, 62526
Contact: Dianna Richardson    217-876-4758    drichardson@dmhhs.org   
Contact: Vijay Damarla    217-876-6600    vjdamarla@outlook.com   
Principal Investigator: James Wade III, MD         
Joliet Oncology-Hematology Associates Ltd. Recruiting
Joliet, Illinois, United States, 60435
Contact: Karen Sceniak    815-730-3098    ksceniak@jolietoncology.com   
Principal Investigator: Nafisa Burhani, MD         
Presence Infusion Care - Skokie Recruiting
Skokie, Illinois, United States, 60077
Contact: Joy Jardinico    224-534-7580    (jjardinico@orchardhr.com   
Principal Investigator: Ira Oliff, MD         
Simmons Cancer Institute at SIU Recruiting
Springfield, Illinois, United States, 62702
Contact: Kathy Robinson    217-545-7489    krobinson@siumed.edu   
Principal Investigator: Pathak Swati, 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, Indiana
American Health Network of Indiana LLC Recruiting
Avon, Indiana, United States, 46123
Contact: Judith Lightfoot    317-745-8000 ext 1079    judy_lightfoot@ahni.com   
Principal Investigator: Sridhar Bolla, MD         
Indiana University Health Goshen Cancer Center Recruiting
Goshen, Indiana, United States, 46526
Contact: Stephen Glick    574-364-2893    sglick@goshenhealth.com   
Contact: Vanessa DePue    574-364-2649    vdepue@goshenhealth.com   
Principal Investigator: Daniel Bruetman, MD         
Community Cancer Research Foundation Recruiting
Munster, Indiana, United States, 46321
Contact: Kimberly Lee       Kimberly.S.Lee@comhs.org   
Principal Investigator: Kassar Mohamad, MD         
Northwest Oncology, P.C. Recruiting
Munster, Indiana, United States, 46321
Contact: Mary Shields    219-836-6879    mshields@comhs.org   
Contact: Michael Tallarico    219-924-8178    mtallarico@nwoncologypc.com   
Principal Investigator: Mohamad Kassar, MD         
United States, Kansas
The University of Kansas Cancer Center (KUCC) Recruiting
Overland Park, Kansas, United States, 66210
Contact: Valerie Francis    913-234-0459    vfrancis@kumc.edu   
Principal Investigator: Richard McKittrick, 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         
United States, Louisiana
Crescent City Research Consortium, LLC Recruiting
Metairie, Louisiana, United States, 70006
Contact: Nicole Guttierrez    504-503-5368    nguttierrez@ejgh.org   
Principal Investigator: Thomas Cosgriff, MD         
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         
Highland Clinic, APMC Recruiting
Shreveport, Louisiana, United States, 71105
Contact: Laura Liu    318-716-4134    Laura.Liu@envisionresearch.org   
Contact: Lauren Scheffy    318-798-4424    LScheffy@Higlandclinic.com   
Principal Investigator: Kirtan Koticha, 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         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Tripp       etripp@partners.org   
Contact: Colleen Griffin       cgriffin9@mgh.harvard.edu   
Principal Investigator: Aitya Bardia, MD         
United States, Missouri
Mercy Hospital St. Louis - Oncology Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Anne Fitzgerald    314-251-7883    anne.fitzgerald@mercy.net   
Principal Investigator: Bethany Sleckman, MD         
United States, New Jersey
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         
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         
Mount Kisco Medical Group (MKMG) Recruiting
Mount Kisco, New York, United States, 10549
Contact: Asha Mellor    914-666-1366    amellor@northwell.edu   
Principal Investigator: Jonathan Goldberg, 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         
White Plains Hospital Center for Cancer Care - Oncology Recruiting
White Plains, New York, United States, 10601
Contact: Joel Victor    914-849-7591    jvictor1@phospital.org   
Principal Investigator: Dan Costin, MD         
United States, Ohio
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Karen Contorno    216-844-4722    Karen.Contorno@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
Gettysburg Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Vanessa Warner    717-334-4033 ext 141    vwarner@gettysburgoncology.com   
Contact: Terry Burke    717-334-4033 ext 131    terry@gettysburgoncology.com   
Principal Investigator: Satish Shah, MD         
Pinnacle Health Cancer Institute Recruiting
Harrisburg, Pennsylvania, United States, 17109
Contact: Bridgett West    717-724-6768    bwest@pinnaclehealth.org   
Principal Investigator: Kit Lu, MD         
United States, South Carolina
Charleston Hematology Oncology Recruiting
Charleston, South Carolina, United States, 29414
Contact: Ashley Morrill       ashley.morrill@choasc.com   
Contact: Stephanie Patel       stephanie.patel@choasc.com   
Principal Investigator: David Ellison, MD         
United States, Tennessee
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
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Carmela Lewis    832-325-7297    carmela.l.lewis@uth.tmc.edu   
Principal Investigator: Anneliese Gonzalez, MD         
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         
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         
Austria
Kepler Universitätsklinikum Recruiting
Linz, Oberösterreich, Austria, 4021
Contact: Bettina Pfleger    +43 (0)5 7680 83 - 6203    bettina.pfleger@kepleruniklinikum.at   
Contact: Marion Mueller    +43 5 7680 83 62 04    marion.mueller@kepleruniklinikum.at   
Principal Investigator: David Fuchs nee Mayr         
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: Christoph Tinchon         
Klinikum Wels-Grieskirchen GmbH Recruiting
Wels, Austria, 4600
Contact: Katharina Schmied    +43 7242 415 3452    Katharina.Schmied@klinikum-wegr.at   
Principal Investigator: Corinna Netolitzky         
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         
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         
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         
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 Hospitalier - Interne Onco-Hematologie Recruiting
La Roche sur Yon, Vendée, France, 85925
Contact: Marie-Line Martin    +33251446161    marie-line.martin@chd-vendee.fr   
Contact: Elsa Bieber    33251446173    elsa.bieber@chd-vendee.fr   
Principal Investigator: Frank Priou         
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         
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         
Hygeia Hospital Recruiting
Marousi, Attiki, Greece, 15123
Contact: Theodoros Poufos    +302106867071    tpoufos@oncologists.gr   
Principal Investigator: Evangelia Razis         
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         
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         
Italy
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         
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 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         
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 Virgen de la Macarena Recruiting
Sevilla, Spain, 41009
Contact: Maria Sánchez    0034 671592620    mluisasleon@gmail.com   
Principal Investigator: Luis de la Cruz Merino         
United Kingdom
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         
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     History of Changes
Other Study ID Numbers: RAD1901-308
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
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
Fulvestrant
Anastrozole
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action