521
Participants
Start Date
September 26, 2013
Primary Completion Date
December 5, 2014
Study Completion Date
September 28, 2022
Palbociclib
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Placebo
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
National Taiwan University Hospital, Taipei
National Cheng Kung University Hospital, Tainan City
Institut Jules Bordet, Brussels
Hopital Erasme, Brussels
Cliniques Universitaires Saint-Luc, Brussels
Clinique Saint-Pierre, Ottignies
Bankstown - Lidcombe Hospital, Bankstown
Calvary Mater Newcastle, Waratah
GZA Ziekenhuizen - Campus St Augustinus, Wilrijk
UZ Antwerpen, Edegem
Imelda Ziekenhuis, Bonheiden
Peter MacCallum Cancer Centre Pharmacy, Melbourne
Peter MacCallum Cancer Centre, Melbourne
UZ Leuven - Campus Gasthuisberg, Leuven
Sunshine Hospital Clinical Trials Pharmacy, St Albans
Sunshine Hospital, St Albans
Cabrini Hospital, Malvern
Monash Medical Centre, Clayton
Cabrini Brighton, Brighton
Peninsula and Southeast Oncology, Frankston
Barwon Health, University Hospital Geelong, Geelong
River City Pharmacy, Auchenflower
Icon Cancer Care Southport, Southport
Sunshine Coast Hospital and Health Service, Nambour
CHU UCL Namur - Site Sainte-Elisabeth, Namur
Grand Hôpital de Charleroi - Site Notre Dame, Charleroi
Fiona Stanley Hospital - Cancer Centre, Murdoch
C.H. de l'Ardenne - site Libramont, Libramont-Chevigny
INDC Entité Jolimontoise - CH de Jolimont-Lobbes, Haine-Saint-Paul
CHWaPi - Site IMC, Tournai
National Cancer Center, Goyang-si
CareMount Medical, Brewster
CareMount Medical, Mount Kisco
Northern Westchester Hospital, Mount Kisco
ProHEALTHCARE Associates, LLP, Lake Success
UPMC Cancer Center, Monroeville, Monroeville
Magee Womens Hospital of UPMC, Pittsburgh
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center, Pittsburgh
Hospital of the University of Pennsylvania, Philadelphia
Thomas Jefferson University, Philadelphia
Farmacia IRCCS Ospedale San Raffaele, Milan
IRCCS Ospedale S. Raffaele, Milan
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Istituto Europeo di Oncologia, Milan
Servizio di Farmacia - Istituto Europeo di Oncologia, Milan
Virginia Cancer Specialists, PC, Leesburg
Podilskyi rehionalnyi tsentr onkolohii,, Vinnytsia
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station, Lutherville
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Baltimore
Inova Medical Group, Fairfax
Inova Schar Cancer Institute, Fairfax
Virginia Cancer Specialists, PC, Fairfax
Virginia Cancer Specialists, PC, Arlington
Shenandoah Oncology, P.C., Winchester
Emily Couric Clinical Cancer Center, Charlottesville
Virginia Oncology Associates, Virginia Beach
Virginia Oncology Associates, Norfolk
Hope Women's Cancer Centers, Asheville
Mission Hospital, Inc., Asheville
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta
Northwest Georgia Oncology Centers, PC, Marietta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Austell
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Cartersville
Piedmont Cancer Institute, PC, Fayetteville
Piedmont Cancer Institute, PC, Atlanta
Orlando Health Cancer Institute, Orlando
Memorial Breast Cancer Center at Memorial Regional Hospital, Hollywood
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood
Memorial Regional Hospital, Hollywood
Memorial Breast Cancer Center at Memorial Hospital West, Pembroke Pines
Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines
Memorial Hospital West, Pembroke Pines
University of Miami Hospitals & Clinics, Miami
Mount Sinai Comprehensive Cancer Center, Miami Beach
Mount Sinai Medical Center, Miami Beach
Mount Sinai Medical Center- Aventura, Aventura
Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale
Sylvester at Plantation, Plantation
Sylvester Comprehensive Cancer Center Deerfield Beach, Deerfield Beach
University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach, Deerfield Beach
Orlando Health, Ocoee
Ege University Medical Faculty, Izmir
University of Alabama at Birmingham, The Kirklin Clinic, Birmingham
UAB Hospital-Investigational Drug Service, Birmingham
University of Alabama at Birmingham, Birmingham
Southern Cancer Center, PC, Daphne
Southern Cancer Center, PC, Mobile
Southern Cancer Center, PC, Mobile
Southern Cancer Center,PC, Mobile
Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis, Legnago (VR)
Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago, Legnago (VR)
The Jones Clinic, PC, Germantown
SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi, Bologna
Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,, Modena
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC)
University of Michigan Health System/Comprehensive Cancer Center, Ann Arbor
Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,, Dnipro
Cancer and Hematology Centers of Western Michigan, Grand Rapids
Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna, Bagno A Ripoli (FI)
S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata, Bagno A Ripoli (FI)
Columbia St. Mary's, Mequon
Columbia St. Mary's, Milwaukee
Fairview Southdale Oncology Clinic, Edina
University of Minnesota Medical Center, Fairview, Minneapolis
University of Minnesota Physicians, Masonic Cancer Center, Minneapolis
"Oblasne komunalne nekomertsiine pidpryiemstvo Bukovynskyi klinichnyi onkolohichnyi tsentr", Chernivtsi
Cancer Treatment Centers of America at Midwestern Regional Medical Center, Zion
Rush University Medical Center, Chicago
"Komunalne nekomertsiyne pidpryiemstvo Oblasnyi", Kharkiv
Mercy Clinic St. Louis Cancer and Breast Institute, Ballwin
Mercy Ministry Office, Chesterfield
Mercy Clinic St. Louis Cancer and Breast Institute, St Louis
Mercy Hospital St. Louis, St Louis
Mercy Hospital St.Louis- David C. Pratt Cancer Center, St Louis
"Komunalna ustanova Odeska oblasna klinichna likarnia", Odesa
US Oncology Investigational Products Center (IPC), Irving
US Oncology lnvestigational Products Center (IPC), Irving
Texas Oncology- Dallas Presbyterian Hospital, Dallas
Texas Oncology- Longview Cancer Center, Longview
Texas Oncology- Tyler, Tyler
Investigational Products Center (IPC), Fort Worth
Cancer Care Centers of South Texas, San Antonio
Cancer Care Centers of South Texas, San Antonio
Cancer Care Centers of South Texas, San Antonio
Texas Oncology- McAllen South Second Street, McAllen
Texas Oncology- Weslaco, Weslaco
KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi, Lviv
ATTN - Research Pharmacist, Aurora
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP), Aurora
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli
Klinikum der Universität München, München
Klinikum der Universität München, München
Huntsman Cancer Hospital, Salt Lake City
Huntsman Cancer Institute, Salt Lake City
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Mesa
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Mesa
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Chandler
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Gilbert
Palo Verde Hematology Oncology, Glendale
Arizona Center for Cancer Care, Glendale
Arizona Center for Cancer Care, Avondale
Western Regional Medical Center, Inc., Goodyear
Arizona Center for Cancer Care, Surprise
The University of Arizona Cancer Center- North Campus, Tucson
The University of Arizona Cancer Center, Tucson
Arizona Oncology Associates, PC- HAL, Flagstaff
Arizona Oncology Associates, PC- HAL, Prescott Valley
Arizona Oncology Associates, PC- HAL, Sedona
Comprehensive Cancer Centers of Nevada, Henderson
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada, Henderson
Comprehensive Cancer Centers of Nevada, Las Vegas
Comprehensive Cancer Centers of Nevada, Las Vegas
Keck Hospital of USC, Los Angeles
LAC & USC Medical Center, Los Angeles
USC/Norris Comprehensive Cancer Center, Los Angeles
UCLA Hematology Oncology, Los Angeles
Administrative Management Only: Translational Research Management, Culver City
UCLA Hematology/Oncology - Santa Monica, Santa Monica
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates, Torrance
Torrance Memorial Physician Network-Cancer Care, Torrance
City of Hope, Duarte
City of Hope, South Pasadena
UCLA Hematology/Oncology - Pasadena, Pasadena
Global Research Management, Glendale
Wellness Oncology & Hematology, West Hills
UCLA Hematology - Oncology Clinic - Westlake Village, Westlake Village
UC San Diego Medical Center-La Jolla, La Jolla
UC San Diego Moores Cancer Center, La Jolla
UC San Diego Medical Center-Hillcrest, San Diego
Breastlink Medical Group, Inc., Santa Ana
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton
Breastlink Medical Group, Inc., Orange
Hematology Oncology Medical Group of Orange County, Inc. (HOMG), Orange
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange, Orange
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center, Bakersfield
San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers, San Luis Obispo
Central Coast Medical Oncology Corporation, Santa Maria
University of California, San Francisco: Helen Diller Comprehensive Cancer Center, San Francisco
"U.O. di Oncologia Medica P.O. Policlinico G. Rodolico", Catania
Swedish Cancer Institute, Seattle
Swedish Medical Center First Hill IDS Pharmacy, Seattle
Swedish Medical Center, Seattle
Spitalul Municipal Ploiesti, Ploieşti
FSBSI Russian Cancer Research Center n.a.NN Blokhin, Moscow
GBUZ Leningrad regional oncological dispensary, Village Kuzmolovsky
"Saint Petersburg GBUZ City Clinical Oncology Dispensary", Saint Petersburg
FGBU Russian Research Center for Radiology and Surgical Technologies, Village Pesochny
Saint Petersburg GBUZ City Clinical Oncology Dispensary, Saint Petersburg
OGBUZ Belgorod Oncology Dispensary, Belgorod
OGBUZ Belgorod Oncology Dispensary, Stariy Oskol
"GBUZ of Stavropol Territory Stavropol Regional Clinical Oncology Dispensary", Stavropol
"FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency", Lermontov
"GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary", Pyatigorsk
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan, Ufa
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine, Chelyabinsk
Spitalul Clinic Judetean Mures, Tg. Mures
"Spitalul Judetean de Urgente Sf. Ioan cel Nou", Suceava
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Brunswick
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Kennebunk
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Scarborough
Rutgers Cancer Institute of New Jersey, New Brunswick
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna
British Columbia Cancer Agency - Fraser Valley Centre, Surrey
Royal Victoria Regional Health Centre, Barrie
Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre, Kingston
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre, Oshawa
The Ottawa Hospital Cancer Centre, General Campus, Ottawa
Niagara Health System Walker Family Cancer Center, St. Catharines
Toronto East General Hospital, Toronto
Sunnybrook Research Institute, Toronto
Princess Margaret Cancer Centre, Toronto
Jewish General Hospital, Montreal
Universitaetsklinikum Leipzig AoeR, Leipzig
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz, Leipzig
Bon Secours Hospital, Cork
Farmacia - Fondazione Policlinico Universitario A. Gemelli, Roma
Fondazione Policlinico Universitario A. Gemelli, Roma
S.C. Oncologia, A.O.S. Maria, Terni
Aichi Cancer Center Hospital, Nagoya
National Cancer Center Hospital East, Kashiwa
National Hospital Organization Shikoku Cancer Center, Matsuyama
Saitama Cancer Center, Kita-adachi-gun
Chiba Cancer Center, Chiba
National Hospital Organization Kyushu Cancer Center, Fukuoka
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima
National Hospital Organization, Osaka
Academisch Ziekenhuis Maastricht, Maastricht
Orbis Medisch Centrum, Sittard-Geleen
TweeSteden Ziekenhuis, Tilburg
Leids Universitair Medisch Centrum, Leiden
Ikazia Ziekenhuis, Rotterdam
Haga Ziekenhuis, The Hague
Champalimaud Cancer Center/ Breast Unit, Lisbon
Instituto Português de Oncologia, Porto
Spitalul Clinic CF nr.2 Bucuresti, Bucharest
Seoul National University Bundang Hospital, Seongnam-si
Seoul National University Hospital, Seoul
Asan medical Center, Seoul
Samsung Medical Center, Seoul
Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre, Portsmouth
Velindre Cancer Centre, Cardiff
Royal Hallamshire Hospital, Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield
The Royal Marsden NHS Foundation Trust, London
The Royal Marsden NHS Foundation Trust, Sutton
Lead Sponsor
Collaborators (1)
AstraZeneca
INDUSTRY
Pfizer
INDUSTRY