Spots Global Cancer Trial Database for Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
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Trial Identification
Brief Title: Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
Official Title: MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Study ID: NCT01942135
Conditions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, The Kirklin Clinic, Birmingham, Alabama, United States
UAB Hospital-Investigational Drug Service, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
Southern Cancer Center, PC, Daphne, Alabama, United States
Southern Cancer Center, PC, Mobile, Alabama, United States
Southern Cancer Center, PC, Mobile, Alabama, United States
Southern Cancer Center,PC, Mobile, Alabama, United States
Arizona Center for Cancer Care, Avondale, Arizona, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Chandler, Arizona, United States
Arizona Oncology Associates, PC- HAL, Flagstaff, Arizona, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Gilbert, Arizona, United States
Palo Verde Hematology Oncology, Glendale, Arizona, United States
Arizona Center for Cancer Care, Glendale, Arizona, United States
Western Regional Medical Center, Inc., Goodyear, Arizona, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Mesa, Arizona, United States
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers, Mesa, Arizona, United States
Arizona Oncology Associates, PC- HAL, Prescott Valley, Arizona, United States
Arizona Oncology Associates, PC- HAL, Sedona, Arizona, United States
Arizona Center for Cancer Care, Surprise, Arizona, United States
The University of Arizona Cancer Center- North Campus, Tucson, Arizona, United States
The University of Arizona Cancer Center, Tucson, Arizona, United States
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Administrative Management Only: Translational Research Management, Culver City, California, United States
City of Hope, Duarte, California, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare, Fullerton, California, United States
Global Research Management, Glendale, California, United States
UC San Diego Medical Center-La Jolla, La Jolla, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Keck Hospital of USC, Los Angeles, California, United States
LAC & USC Medical Center, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Hematology Oncology, Los Angeles, California, United States
Breastlink Medical Group, Inc., Orange, California, United States
Hematology Oncology Medical Group of Orange County, Inc. (HOMG), Orange, California, United States
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange, Orange, California, United States
UCLA Hematology/Oncology - Pasadena, Pasadena, California, United States
UC San Diego Medical Center-Hillcrest, San Diego, California, United States
University of California, San Francisco: Helen Diller Comprehensive Cancer Center, San Francisco, California, United States
San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers, San Luis Obispo, California, United States
Breastlink Medical Group, Inc., Santa Ana, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
City of Hope, South Pasadena, California, United States
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates, Torrance, California, United States
Torrance Memorial Physician Network-Cancer Care, Torrance, California, United States
Wellness Oncology & Hematology, West Hills, California, United States
UCLA Hematology - Oncology Clinic - Westlake Village, Westlake Village, California, United States
ATTN - Research Pharmacist, Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP), Aurora, Colorado, United States
Mount Sinai Medical Center- Aventura, Aventura, Florida, United States
Sylvester Comprehensive Cancer Center Deerfield Beach, Deerfield Beach, Florida, United States
University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach, Deerfield Beach, Florida, United States
Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale, Florida, United States
Memorial Breast Cancer Center at Memorial Regional Hospital, Hollywood, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States
Memorial Regional Hospital, Hollywood, Florida, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Miami Hospitals & Clinics, Miami, Florida, United States
Orlando Health, Ocoee, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Memorial Breast Cancer Center at Memorial Hospital West, Pembroke Pines, Florida, United States
Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines, Florida, United States
Memorial Hospital West, Pembroke Pines, Florida, United States
Sylvester at Plantation, Plantation, Florida, United States
Piedmont Cancer Institute, PC, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Austell, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Cartersville, Georgia, United States
Piedmont Cancer Institute, PC, Fayetteville, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta, Georgia, United States
Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center, Zion, Illinois, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Brunswick, Maine, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Kennebunk, Maine, United States
Maine Center for Cancer Medicine, dba: New England Cancer Specialists, Scarborough, Maine, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station, Lutherville, Maryland, United States
University of Michigan Health System/Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Fairview Southdale Oncology Clinic, Edina, Minnesota, United States
University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota, United States
University of Minnesota Physicians, Masonic Cancer Center, Minneapolis, Minnesota, United States
Mercy Clinic St. Louis Cancer and Breast Institute, Ballwin, Missouri, United States
Mercy Ministry Office, Chesterfield, Missouri, United States
Mercy Clinic St. Louis Cancer and Breast Institute, Saint Louis, Missouri, United States
Mercy Hospital St. Louis, Saint Louis, Missouri, United States
Mercy Hospital St.Louis- David C. Pratt Cancer Center, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
CareMount Medical, Brewster, New York, United States
ProHEALTHCARE Associates, LLP, Lake Success, New York, United States
CareMount Medical, Mount Kisco, New York, United States
Northern Westchester Hospital, Mount Kisco, New York, United States
Hope Women's Cancer Centers, Asheville, North Carolina, United States
Mission Hospital, Inc., Asheville, North Carolina, United States
UPMC Cancer Center, Monroeville, Monroeville, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
The Jones Clinic, PC, Germantown, Tennessee, United States
Texas Oncology- Dallas Presbyterian Hospital, Dallas, Texas, United States
Investigational Products Center (IPC), Fort Worth, Texas, United States
US Oncology Investigational Products Center (IPC), Irving, Texas, United States
US Oncology lnvestigational Products Center (IPC), Irving, Texas, United States
Texas Oncology- Longview Cancer Center, Longview, Texas, United States
Texas Oncology- McAllen South Second Street, McAllen, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Texas Oncology- Tyler, Tyler, Texas, United States
Texas Oncology- Weslaco, Weslaco, Texas, United States
Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Arlington, Virginia, United States
Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
Inova Medical Group, Fairfax, Virginia, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Cancer Specialists, PC, Leesburg, Virginia, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Virginia Oncology Associates, Virginia Beach, Virginia, United States
Shenandoah Oncology, P.C., Winchester, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Swedish Medical Center First Hill IDS Pharmacy, Seattle, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
Columbia St. Mary's, Mequon, Wisconsin, United States
Columbia St. Mary's, Milwaukee, Wisconsin, United States
Bankstown - Lidcombe Hospital, Bankstown, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
River City Pharmacy, Auchenflower, Queensland, Australia
Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia
Icon Cancer Care Southport, Southport, Queensland, Australia
Cabrini Brighton, Brighton, Victoria, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Peninsula and Southeast Oncology, Frankston, Victoria, Australia
Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia
Cabrini Hospital, Malvern, Victoria, Australia
Peter MacCallum Cancer Centre Pharmacy, Melbourne, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Sunshine Hospital Clinical Trials Pharmacy, St Albans, Victoria, Australia
Sunshine Hospital, St Albans, Victoria, Australia
Fiona Stanley Hospital - Cancer Centre, Murdoch, Western Australia, Australia
UZ Antwerpen, Edegem, Antwerpen, Belgium
Clinique Saint-Pierre, Ottignies, Brabant Wallon, Belgium
Institut Jules Bordet, Bruxelles, Bruxelles Capitale, Belgium
Grand Hôpital de Charleroi - Site Notre Dame, Charleroi, Hainaut, Belgium
INDC Entité Jolimontoise - CH de Jolimont-Lobbes, Haine St. Paul, Hainaut, Belgium
CHWaPi - Site IMC, Tournai, Hainaut, Belgium
C.H. de l'Ardenne - site Libramont, Libramont-Chevigny, Luxembourg, Belgium
Hopital Erasme, Bruxelles, Region DE Bruxelles-capital, Belgium
Imelda Ziekenhuis, Bonheiden, , Belgium
Cliniques Universitaires Saint-Luc, Bruxelles, , Belgium
UZ Leuven - Campus Gasthuisberg, Leuven, , Belgium
CHU UCL Namur - Site Sainte-Elisabeth, Namur, , Belgium
GZA Ziekenhuizen - Campus St Augustinus, Wilrijk, , Belgium
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior, Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Fraser Valley Centre, Surrey, British Columbia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre, Kingston, Ontario, Canada
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, General Campus, Ottawa, Ontario, Canada
Niagara Health System Walker Family Cancer Center, St. Catharines, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Universitaetsklinikum Leipzig AoeR, Leipzig, , Germany
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz, Leipzig, , Germany
Klinikum der Universität München, München, , Germany
Klinikum der Universität München, München, , Germany
Bon Secours Hospital, Cork, , Ireland
Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna, Bagno A Ripoli (FI), , Italy
S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata, Bagno A Ripoli (FI), , Italy
SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi, Bologna, , Italy
U.O. di Oncologia Medica P.O. Policlinico G. Rodolico", Catania, , Italy
Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis, Legnago (VR), , Italy
Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago, Legnago (VR), , Italy
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (FC), , Italy
Farmacia IRCCS Ospedale San Raffaele, Milano, , Italy
IRCCS Ospedale S. Raffaele, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Servizio di Farmacia - Istituto Europeo di Oncologia, Milano, , Italy
Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,, Modena, , Italy
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli, , Italy
Farmacia - Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli, Roma, , Italy
S.C. Oncologia, A.O.S. Maria, Terni, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama-city, Ehime, Japan
Saitama Cancer Center, Kita-adachi-gun, Saitama,japan, Japan
Chiba Cancer Center, Chiba, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Hakuaikai Medical Corporation Sagara Hospital, Kagoshima, , Japan
National Hospital Organization, Osaka, , Japan
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Academisch Ziekenhuis Maastricht, Maastricht, Limburg, Netherlands
Orbis Medisch Centrum, Sittard-Geleen, Limburg, Netherlands
TweeSteden Ziekenhuis, Tilburg, Noord-brabant, Netherlands
Haga Ziekenhuis, Den Haag, Zuid-holland, Netherlands
Leids Universitair Medisch Centrum, Leiden, Zuid-holland, Netherlands
Ikazia Ziekenhuis, Rotterdam, Zuid-holland, Netherlands
Champalimaud Cancer Center/ Breast Unit, Lisboa, , Portugal
Instituto Português de Oncologia, Porto, , Portugal
Spitalul Clinic CF nr.2 Bucuresti, Bucharest, , Romania
Spitalul Municipal Ploiesti, Ploiesti, , Romania
Spitalul Judetean de Urgente "Sf. Ioan cel Nou", Suceava, , Romania
Spitalul Clinic Judetean Mures, Tg. Mures, , Romania
OGBUZ Belgorod Oncology Dispensary, Belgorod,, Belgorodskaya Oblast',, Russian Federation
OGBUZ Belgorod Oncology Dispensary, Stariy Oskol, Belgorodskaya Oblast', Russian Federation
GBUZ Leningrad regional oncological dispensary, Village Kuzmolovsky, Leningradskaya Oblast', Russian Federation
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan, Ufa, Republic OF Bashkortostan, Russian Federation
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency", Lermontov, Stavropol Territory, Russian Federation
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary", Pyatigorsk,, Stavropol Territory, Russian Federation
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine, Chelyabinsk, , Russian Federation
FSBSI Russian Cancer Research Center n.a.NN Blokhin, Moscow, , Russian Federation
Saint Petersburg GBUZ "City Clinical Oncology Dispensary", Saint Petersburg, , Russian Federation
Saint Petersburg GBUZ City Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary", Stavropol, , Russian Federation
FGBU Russian Research Center for Radiology and Surgical Technologies, Village Pesochny, , Russian Federation
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Ege University Medical Faculty, Izmir, Bornova, Turkey
Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", Chernivtsi, , Ukraine
Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,, Dnipro, , Ukraine
Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi, Kharkiv, , Ukraine
KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi, Lviv, , Ukraine
Komunalna ustanova "Odeska oblasna klinichna likarnia", Odesa, , Ukraine
Podilskyi rehionalnyi tsentr onkolohii,, Vinnytsia, , Ukraine
Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre, Portsmouth, Hampshire, United Kingdom
Velindre Cancer Centre, Cardiff, South Glamorgan, United Kingdom
Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital, Sheffield, South Yorkshire, United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom
Contact Details
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Affiliation: Pfizer
Role: STUDY_DIRECTOR
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