Breast Cancer Clinical Trial

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
Confirmed diagnosis of HR+/HER2- breast cancer
Any menopausal status
Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
Measurable disease defined by RECIST version 1.1, or bone-only disease
Eastern Cooperative Oncology Group (ECOG) PS 0-1
Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
Major surgery or any anti-cancer therapy within 2 weeks of randomization
Prior stem cell or bone marrow transplantation
Use of potent CYP3A4 inhibitors or inducers

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

523

Study ID:

NCT01942135

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 207 Locations for this study

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University of Alabama at Birmingham, The Kirklin Clinic
Birmingham Alabama, 35233, United States
UAB Hospital-Investigational Drug Service
Birmingham Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
Southern Cancer Center, PC
Daphne Alabama, 36526, United States
Southern Cancer Center, PC
Mobile Alabama, 36607, United States
Southern Cancer Center, PC
Mobile Alabama, 36608, United States
Southern Cancer Center,PC
Mobile Alabama, 36608, United States
Arizona Center for Cancer Care
Avondale Arizona, 85323, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Arizona Oncology Associates, PC- HAL
Flagstaff Arizona, 86001, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Gilbert Arizona, 85297, United States
Palo Verde Hematology Oncology
Glendale Arizona, 85304, United States
Arizona Center for Cancer Care
Glendale Arizona, 85306, United States
Western Regional Medical Center, Inc.
Goodyear Arizona, 85338, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Mesa Arizona, 85202, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Mesa Arizona, 85206, United States
Arizona Oncology Associates, PC- HAL
Prescott Valley Arizona, 86314, United States
Arizona Oncology Associates, PC- HAL
Sedona Arizona, 86336, United States
Arizona Center for Cancer Care
Surprise Arizona, 85374, United States
The University of Arizona Cancer Center- North Campus
Tucson Arizona, 85719, United States
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Administrative Management Only: Translational Research Management
Culver City California, 90232, United States
City of Hope
Duarte California, 91010, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton California, 92835, United States
Global Research Management
Glendale California, 91204, United States
UC San Diego Medical Center-La Jolla
La Jolla California, 92037, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
LAC & USC Medical Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
UCLA Hematology Oncology
Los Angeles California, 90095, United States
Breastlink Medical Group, Inc.
Orange California, 92868, United States
Hematology Oncology Medical Group of Orange County, Inc. (HOMG)
Orange California, 92868, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange California, 92868, United States
UCLA Hematology/Oncology - Pasadena
Pasadena California, 91105, United States
UC San Diego Medical Center-Hillcrest
San Diego California, 92103, United States
University of California, San Francisco: Helen Diller Comprehensive Cancer Center
San Francisco California, 94115, United States
San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
San Luis Obispo California, 93401, United States
Breastlink Medical Group, Inc.
Santa Ana California, 92705, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica California, 90404, United States
City of Hope
South Pasadena California, 91030, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
Torrance California, 90505, United States
Torrance Memorial Physician Network-Cancer Care
Torrance California, 90505, United States
Wellness Oncology & Hematology
West Hills California, 91307, United States
UCLA Hematology - Oncology Clinic - Westlake Village
Westlake Village California, 91361, United States
ATTN - Research Pharmacist
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora Colorado, 80045, United States
Mount Sinai Medical Center- Aventura
Aventura Florida, 33180, United States
Sylvester Comprehensive Cancer Center Deerfield Beach
Deerfield Beach Florida, 33442, United States
University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach
Deerfield Beach Florida, 33442, United States
Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale Florida, 33308, United States
Memorial Breast Cancer Center at Memorial Regional Hospital
Hollywood Florida, 33021, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood Florida, 33021, United States
Memorial Regional Hospital
Hollywood Florida, 33021, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Orlando Health
Ocoee Florida, 34761, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Memorial Breast Cancer Center at Memorial Hospital West
Pembroke Pines Florida, 33028, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines Florida, 33028, United States
Memorial Hospital West
Pembroke Pines Florida, 33028, United States
Sylvester at Plantation
Plantation Florida, 33324, United States
Piedmont Cancer Institute, PC
Atlanta Georgia, 30318, United States
Piedmont Cancer Institute, PC
Fayetteville Georgia, 30214, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta Georgia, 30060, United States
Northwest Georgia Oncology Centers, PC
Marietta Georgia, 30060, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion Illinois, 60099, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists
Brunswick Maine, 04011, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists
Kennebunk Maine, 04043, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists
Scarborough Maine, 04074, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
Baltimore Maryland, 21231, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
Lutherville Maryland, 21093, United States
University of Michigan Health System/Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids Michigan, 49503, United States
Fairview Southdale Oncology Clinic
Edina Minnesota, 55435, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin Missouri, 63011, United States
Mercy Ministry Office
Chesterfield Missouri, 63017, United States
Mercy Clinic St. Louis Cancer and Breast Institute
Saint Louis Missouri, 63109, United States
Mercy Hospital St. Louis
Saint Louis Missouri, 63141, United States
Mercy Hospital St.Louis- David C. Pratt Cancer Center
Saint Louis Missouri, 63141, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
CareMount Medical
Brewster New York, 10509, United States
ProHEALTHCARE Associates, LLP
Lake Success New York, 11042, United States
CareMount Medical
Mount Kisco New York, 10549, United States
Northern Westchester Hospital
Mount Kisco New York, 10549, United States
Hope Women's Cancer Centers
Asheville North Carolina, 28806, United States
Mission Hospital, Inc.
Asheville North Carolina, 28806, United States
UPMC Cancer Center, Monroeville
Monroeville Pennsylvania, 15146, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Magee Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
The Jones Clinic, PC
Germantown Tennessee, 38138, United States
Texas Oncology- Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Investigational Products Center (IPC)
Fort Worth Texas, 76177, United States
US Oncology Investigational Products Center (IPC)
Irving Texas, 75063, United States
US Oncology lnvestigational Products Center (IPC)
Irving Texas, 75063, United States
Texas Oncology- Longview Cancer Center
Longview Texas, 75601, United States
Texas Oncology- McAllen South Second Street
McAllen Texas, 78503, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78212, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78217, United States
Cancer Care Centers of South Texas
San Antonio Texas, 78258, United States
Texas Oncology- Tyler
Tyler Texas, 75702, United States
Texas Oncology- Weslaco
Weslaco Texas, 78596, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Cancer Specialists, PC
Arlington Virginia, 22205, United States
Emily Couric Clinical Cancer Center
Charlottesville Virginia, 22903, United States
Inova Medical Group
Fairfax Virginia, 22031, United States
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Virginia Cancer Specialists, PC
Leesburg Virginia, 20176, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach Virginia, 23456, United States
Shenandoah Oncology, P.C.
Winchester Virginia, 22601, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Swedish Medical Center First Hill IDS Pharmacy
Seattle Washington, 98104, United States
Swedish Medical Center
Seattle Washington, 98122, United States
Columbia St. Mary's
Mequon Wisconsin, 53097, United States
Columbia St. Mary's
Milwaukee Wisconsin, 53211, United States
Bankstown - Lidcombe Hospital
Bankstown New South Wales, 2200, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
River City Pharmacy
Auchenflower Queensland, 4066, Australia
Sunshine Coast Hospital and Health Service
Nambour Queensland, 4560, Australia
Icon Cancer Care Southport
Southport Queensland, 4215, Australia
Cabrini Brighton
Brighton Victoria, 3186, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Peninsula and Southeast Oncology
Frankston Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong Victoria, 3220, Australia
Cabrini Hospital
Malvern Victoria, 3144, Australia
Peter MacCallum Cancer Centre Pharmacy
Melbourne Victoria, 3000, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Sunshine Hospital Clinical Trials Pharmacy
St Albans Victoria, 3021, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Fiona Stanley Hospital - Cancer Centre
Murdoch Western Australia, 6150, Australia
UZ Antwerpen
Edegem Antwerpen, 2650, Belgium
Clinique Saint-Pierre
Ottignies Brabant Wallon, 1340, Belgium
Institut Jules Bordet
Bruxelles Bruxelles Capitale, 1000, Belgium
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi Hainaut, 6000, Belgium
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine St. Paul Hainaut, 7100, Belgium
CHWaPi - Site IMC
Tournai Hainaut, 7500, Belgium
C.H. de l'Ardenne - site Libramont
Libramont-Chevigny Luxembourg, 6800, Belgium
Hopital Erasme
Bruxelles Region DE Bruxelles-capital, 1070, Belgium
Imelda Ziekenhuis
Bonheiden , 2820, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
CHU UCL Namur - Site Sainte-Elisabeth
Namur , 5000, Belgium
GZA Ziekenhuizen - Campus St Augustinus
Wilrijk , 2610, Belgium
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
Kelowna British Columbia, V1Y 5, Canada
British Columbia Cancer Agency - Fraser Valley Centre
Surrey British Columbia, V3V 1, Canada
Royal Victoria Regional Health Centre
Barrie Ontario, L4M 6, Canada
Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre
Kingston Ontario, K7L 2, Canada
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre, General Campus
Ottawa Ontario, K1H 8, Canada
Niagara Health System Walker Family Cancer Center
St. Catharines Ontario, L2S 0, Canada
Toronto East General Hospital
Toronto Ontario, M4C 3, Canada
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Universitaetsklinikum Leipzig AoeR
Leipzig , 04103, Germany
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz
Leipzig , 04103, Germany
Klinikum der Universität München
München , 80336, Germany
Klinikum der Universität München
München , 80337, Germany
Bon Secours Hospital
Cork , , Ireland
Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna
Bagno A Ripoli (FI) , 50012, Italy
S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata
Bagno A Ripoli (FI) , 50012, Italy
SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi
Bologna , 40138, Italy
U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"
Catania , 95123, Italy
Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis
Legnago (VR) , 37045, Italy
Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago
Legnago (VR) , 37045, Italy
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC) , 47014, Italy
Farmacia IRCCS Ospedale San Raffaele
Milano , 20132, Italy
IRCCS Ospedale S. Raffaele
Milano , 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Istituto Europeo di Oncologia
Milano , 20141, Italy
Servizio di Farmacia - Istituto Europeo di Oncologia
Milano , 20141, Italy
Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,
Modena , 41124, Italy
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori
Napoli , 80131, Italy
Farmacia - Fondazione Policlinico Universitario A. Gemelli
Roma , 00168, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma , 00168, Italy
S.C. Oncologia, A.O.S. Maria
Terni , 05100, Italy
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama-city Ehime, 791-0, Japan
Saitama Cancer Center
Kita-adachi-gun Saitama,japan, 362-0, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima , 892-0, Japan
National Hospital Organization
Osaka , 540-0, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, 463-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Academisch Ziekenhuis Maastricht
Maastricht Limburg, 6229 , Netherlands
Orbis Medisch Centrum
Sittard-Geleen Limburg, 6162 , Netherlands
TweeSteden Ziekenhuis
Tilburg Noord-brabant, 5042A, Netherlands
Haga Ziekenhuis
Den Haag Zuid-holland, 2545 , Netherlands
Leids Universitair Medisch Centrum
Leiden Zuid-holland, 2333Z, Netherlands
Ikazia Ziekenhuis
Rotterdam Zuid-holland, 3083 , Netherlands
Champalimaud Cancer Center/ Breast Unit
Lisboa , 1400-, Portugal
Instituto Português de Oncologia
Porto , 4200-, Portugal
Spitalul Clinic CF nr.2 Bucuresti
Bucharest , 01146, Romania
Spitalul Municipal Ploiesti
Ploiesti , 10033, Romania
Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
Suceava , 72023, Romania
Spitalul Clinic Judetean Mures
Tg. Mures , 54014, Romania
OGBUZ Belgorod Oncology Dispensary
Belgorod, Belgorodskaya Oblast',, 30801, Russian Federation
OGBUZ Belgorod Oncology Dispensary
Stariy Oskol Belgorodskaya Oblast', 30950, Russian Federation
GBUZ Leningrad regional oncological dispensary
Village Kuzmolovsky Leningradskaya Oblast', 18866, Russian Federation
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
Ufa Republic OF Bashkortostan, 45005, Russian Federation
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
Lermontov Stavropol Territory, 35734, Russian Federation
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, 35750, Russian Federation
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
Chelyabinsk , 45408, Russian Federation
FSBSI Russian Cancer Research Center n.a.NN Blokhin
Moscow , 11547, Russian Federation
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
Saint Petersburg , 19702, Russian Federation
Saint Petersburg GBUZ City Clinical Oncology Dispensary
Saint Petersburg , 19825, Russian Federation
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol , 35504, Russian Federation
FGBU Russian Research Center for Radiology and Surgical Technologies
Village Pesochny , 19775, Russian Federation
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 100, Taiwan
Ege University Medical Faculty
Izmir Bornova, 35040, Turkey
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"
Chernivtsi , 58013, Ukraine
Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,
Dnipro , 49102, Ukraine
Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi
Kharkiv , 61070, Ukraine
KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi
Lviv , 79031, Ukraine
Komunalna ustanova "Odeska oblasna klinichna likarnia"
Odesa , 65025, Ukraine
Podilskyi rehionalnyi tsentr onkolohii,
Vinnytsia , 21029, Ukraine
Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre
Portsmouth Hampshire, PO6 3, United Kingdom
Velindre Cancer Centre
Cardiff South Glamorgan, CF14 , United Kingdom
Royal Hallamshire Hospital
Sheffield South Yorkshire, S10 2, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
Sheffield South Yorkshire, S10 2, United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

523

Study ID:

NCT01942135

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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