Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
NCT ID: NCT01942135
Last Updated: 2024-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
521 participants
INTERVENTIONAL
2013-09-26
2022-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
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.
Arm B
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
University of Miami Hospitals & Clinics
Miami, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Mount Sinai Medical Center
Miami Beach, 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
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Mercy Hospital St.Louis- David C. Pratt Cancer Center
St 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
Brussels, Brussels Capital, Belgium
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, Hainaut, Belgium
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine-Saint-Paul, Hainaut, Belgium
CHWaPi - Site IMC
Tournai, Hainaut, Belgium
C.H. de l'Ardenne - site Libramont
Libramont-Chevigny, Luxembourg, Belgium
Hopital Erasme
Brussels, Region de Bruxelles-capital, Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , 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
Milan, , Italy
IRCCS Ospedale S. Raffaele
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Servizio di Farmacia - Istituto Europeo di Oncologia
Milan, , 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-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, 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
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, Netherlands
Orbis Medisch Centrum
Sittard-Geleen, Limburg, Netherlands
TweeSteden Ziekenhuis
Tilburg, North Brabant, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
Ikazia Ziekenhuis
Rotterdam, South Holland, Netherlands
Haga Ziekenhuis
The Hague, South Holland, Netherlands
Champalimaud Cancer Center/ Breast Unit
Lisbon, , Portugal
Instituto Português de Oncologia
Porto, , Portugal
Spitalul Clinic CF nr.2 Bucuresti
Bucharest, , Romania
Spitalul Municipal Ploiesti
Ploieşti, , Romania
Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
Suceava, , Romania
Spitalul Clinic Judetean Mures
Tg. Mures, , Romania
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
Ufa, Bashkortostan Republic, Russia
OGBUZ Belgorod Oncology Dispensary
Belgorod, Belgorod Oblast, Russia
OGBUZ Belgorod Oncology Dispensary
Stariy Oskol, Belgorod Oblast, Russia
GBUZ Leningrad regional oncological dispensary
Village Kuzmolovsky, Leningradskaya Oblast', Russia
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
Lermontov, Stavropol Territory, Russia
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, Russia
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
Chelyabinsk, , Russia
FSBSI Russian Cancer Research Center n.a.NN Blokhin
Moscow, , Russia
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
Saint Petersburg, , Russia
Saint Petersburg GBUZ City Clinical Oncology Dispensary
Saint Petersburg, , Russia
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol, , Russia
FGBU Russian Research Center for Radiology and Surgical Technologies
Village Pesochny, , Russia
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Ege University Medical Faculty
Izmir, Bornova, Turkey (Türkiye)
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
Countries
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References
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Masuda N, Inoue K, Nakamura R, Rai Y, Mukai H, Ohno S, Hara F, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Huang X, Iwata H. Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients. Int J Clin Oncol. 2019 Mar;24(3):262-273. doi: 10.1007/s10147-018-1359-3. Epub 2018 Nov 3.
Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Andre F, Puyana Theall K, Huang X, Giorgetti C, Huang Bartlett C, Cristofanilli M. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018 Nov 15;379(20):1926-1936. doi: 10.1056/NEJMoa1810527. Epub 2018 Oct 20.
Cristofanilli M, DeMichele A, Giorgetti C, Turner NC, Slamon DJ, Im SA, Masuda N, Verma S, Loi S, Colleoni M, Theall KP, Huang X, Liu Y, Bartlett CH. Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3. Eur J Cancer. 2018 Nov;104:21-31. doi: 10.1016/j.ejca.2018.08.011. Epub 2018 Oct 8.
Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.
Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.
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Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Dieras V, Moulder S, Lipatov O, Colleoni M, Cristofanilli M, Lu DR, Mori A, Giorgetti C, Iyer S, Bartlett CH, Gelmon KA. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018 Mar 1;29(3):669-680. doi: 10.1093/annonc/mdx797.
Loibl S, Turner NC, Ro J, Cristofanilli M, Iwata H, Im SA, Masuda N, Loi S, Andre F, Harbeck N, Verma S, Folkerd E, Puyana Theall K, Hoffman J, Zhang K, Bartlett CH, Dowsett M. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results. Oncologist. 2017 Sep;22(9):1028-1038. doi: 10.1634/theoncologist.2017-0072. Epub 2017 Jun 26.
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Fribbens C, O'Leary B, Kilburn L, Hrebien S, Garcia-Murillas I, Beaney M, Cristofanilli M, Andre F, Loi S, Loibl S, Jiang J, Bartlett CH, Koehler M, Dowsett M, Bliss JM, Johnston SR, Turner NC. Plasma ESR1 Mutations and the Treatment of Estrogen Receptor-Positive Advanced Breast Cancer. J Clin Oncol. 2016 Sep 1;34(25):2961-8. doi: 10.1200/JCO.2016.67.3061. Epub 2016 Jun 6.
Harbeck N, Iyer S, Turner N, Cristofanilli M, Ro J, Andre F, Loi S, Verma S, Iwata H, Bhattacharyya H, Puyana Theall K, Bartlett CH, Loibl S. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann Oncol. 2016 Jun;27(6):1047-1054. doi: 10.1093/annonc/mdw139. Epub 2016 Mar 30.
Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.
Turner NC, Ro J, Andre F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, Giorgetti C, Randolph S, Koehler M, Cristofanilli M; PALOMA3 Study Group. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Jul 16;373(3):209-19. doi: 10.1056/NEJMoa1505270. Epub 2015 Jun 1.
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
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Other Identifiers
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2013-002580-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A5481023
Identifier Type: -
Identifier Source: org_study_id
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