Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
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
2 other identifiers
interventional
521
17 countries
247
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2013
Longer than P75 for phase_3
247 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedStudy Start
First participant enrolled
September 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2014
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2022
CompletedApril 4, 2024
April 1, 2024
1.2 years
September 10, 2013
December 3, 2015
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as Assessed by the Investigator
PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =\[progression/death date(censor date) - randomization date + 1\]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.
From randomization date to date of first documentation of progression or death (assessed up to 12 months)
Secondary Outcomes (19)
Overall Survival (OS)-Number of Participants Who Died
From randomization until death (up to 4.5 years)
Overall Survival (OS)
From randomization until death (up to 4.5 years)
Survival Probabilities at Year 1, Year 2, and Year 3
From randomization until death (assessed up to 36 months)
Objective Response (OR)
From randomization until end of treatment (assessed up to 2 years)
Duration of Response (DR)
From randomization until end of treatment (assessed up to 2 years)
- +14 more secondary outcomes
Study Arms (2)
Arm A
EXPERIMENTALGiven until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Arm B
ACTIVE COMPARATORGiven until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Interventions
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- AstraZenecacollaborator
Study Sites (247)
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
University of Miami Hospitals & Clinics
Miami, Florida, 33136, 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
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Austell, Georgia, 30106, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
Cartersville, Georgia, 30121, 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
St Louis, Missouri, 63109, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Mercy Hospital St.Louis- David C. Pratt Cancer Center
St 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
Brussels, Brussels Capital, 1000, Belgium
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, Hainaut, 6000, Belgium
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine-Saint-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
Brussels, Region de Bruxelles-capital, 1070, Belgium
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 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 5L3, Canada
British Columbia Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, V3V 1Z2, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Cancer Centre, General Campus
Ottawa, Ontario, K1H 8L6, Canada
Niagara Health System Walker Family Cancer Center
St. Catharines, Ontario, L2S 0A9, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, 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
Milan, 20132, Italy
IRCCS Ospedale S. Raffaele
Milan, 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Servizio di Farmacia - Istituto Europeo di Oncologia
Milan, 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-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
Saitama Cancer Center
Kita-adachi-gun, Saitama,japan, 362-0806, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, 892-0833, Japan
National Hospital Organization
Osaka, 540-0006, Japan
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, 6229 HX, Netherlands
Orbis Medisch Centrum
Sittard-Geleen, Limburg, 6162 BG, Netherlands
TweeSteden Ziekenhuis
Tilburg, North Brabant, 5042AD, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333ZA, Netherlands
Ikazia Ziekenhuis
Rotterdam, South Holland, 3083 AN, Netherlands
Haga Ziekenhuis
The Hague, South Holland, 2545 AA, Netherlands
Champalimaud Cancer Center/ Breast Unit
Lisbon, 1400-038, Portugal
Instituto Português de Oncologia
Porto, 4200-072, Portugal
Spitalul Clinic CF nr.2 Bucuresti
Bucharest, 011464, Romania
Spitalul Municipal Ploiesti
Ploieşti, 100337, Romania
Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
Suceava, 720237, Romania
Spitalul Clinic Judetean Mures
Tg. Mures, 540142, Romania
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
Ufa, Bashkortostan Republic, 450054, Russia
OGBUZ Belgorod Oncology Dispensary
Belgorod, Belgorod Oblast, 308010, Russia
OGBUZ Belgorod Oncology Dispensary
Stariy Oskol, Belgorod Oblast, 309504, Russia
GBUZ Leningrad regional oncological dispensary
Village Kuzmolovsky, Leningradskaya Oblast', 188663, Russia
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
Lermontov, Stavropol Territory, 357340, Russia
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory, 357502, Russia
GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
Chelyabinsk, 454087, Russia
FSBSI Russian Cancer Research Center n.a.NN Blokhin
Moscow, 115478, Russia
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
Saint Petersburg, 197022, Russia
Saint Petersburg GBUZ City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol, 355047, Russia
FGBU Russian Research Center for Radiology and Surgical Technologies
Village Pesochny, 197758, Russia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Ege University Medical Faculty
Izmir, Bornova, 35040, Turkey (Türkiye)
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 3LY, United Kingdom
Velindre Cancer Centre
Cardiff, South Glamorgan, CF14 2TL, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
Sheffield, South Yorkshire, S10 2SJ, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (23)
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PMID: 36463643DERIVEDZhu Z, Turner NC, Loi S, Andre F, Martin M, Dieras V, Gelmon KA, Harbeck N, Zhang C, Cao JQ, Yan Z, Lu DR, Wei P, VanArsdale TL, Rejto PA, Huang X, Rugo HS, Loibl S, Cristofanilli M, Finn RS, Liu Y. Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib. NPJ Precis Oncol. 2022 Aug 16;6(1):56. doi: 10.1038/s41698-022-00297-1.
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Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2013
First Posted
September 13, 2013
Study Start
September 26, 2013
Primary Completion
December 5, 2014
Study Completion
September 28, 2022
Last Updated
April 4, 2024
Results First Posted
May 23, 2016
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.