A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

October 22, 2024 updated by: Pfizer

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

666

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent's Hospital Sydney
      • Port Macquarie, New South Wales, Australia, 2444
        • Laverty Pathology
      • Port Macquarie, New South Wales, Australia, 2444
        • Mid North Coast Diagnostic Imaging
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • ICON Cancer Care
      • Birtinya, Queensland, Australia, 4575
        • Sunshine Coast University Hospital
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Care Corporate Office
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Bendigo Health Care Group, The Bendigo Hospital Campus
      • Epping, Victoria, Australia, 3076
        • Northern Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Richmond, Victoria, Australia, 3121
        • Epworth Healthcare
      • Ringwood East, Victoria, Australia, 3135
        • Maroondah Hospital
      • Shepparton, Victoria, Australia, 3630
        • Goulburn Valley Health
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1200
        • Oncologie
      • Charleroi, Belgium, 6000
        • Grand Hopital de Charleroi / Service d'Hematologie et Oncologie
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
      • Liege, Belgium, 4000
        • CHU Start Tilman
      • Verviers, Belgium, 4800
        • CHR East Belgium - Verviers
    • Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • Gasthuis Zusters Antwerpen - Campus Sint- Augustinus
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BC Cancer Agency-Fraser Valley Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency-Vancouver Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre, Victoria General Site
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Newmarket, Ontario, Canada, L3Y2P9
        • Southlake Regional Health Centre- Stronach Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michaels Hospital
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Du Sacre-Coeur
      • Quebec City, Quebec, Canada, G1S 4L8
        • Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie
  • France
      • Anger Cedex 02, France, 49055
        • Institut de Cancerologie de l'Ouest- Paul Papin
      • Caen Cedex 5, France, 14076
        • Centre Francois Baclesse
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • La Roche Sur Yon, France, 85295
        • CHD Vendee
      • Montpellier CEDEX 5, France, 34298
        • Centre Val d'Aurelle,
      • Nice cedex 2, France, 06189
        • Centre Antoine Lacassagne
      • Paris Cedex 05, France, 75248
        • Institut Curie, Departement d'Oncologie Medicale
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Saint-Cloud, France, 92210
        • Hopital Rene Huguenin/Institut Curie
      • St Herblain, France, 44805
        • Institut de Cancerologie de l'Ouest-Rene Gauducheau
      • Toulouse CEDEX-9, France, 31059
        • Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Boblingen, Germany, 71032
        • Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen
      • Dresden, Germany, 01307
        • University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Frauenklinik
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe
      • Magdeburg, Germany, 39108
        • Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik
      • Mainz, Germany, 55131
        • Katholisches Klinikum Mainz
      • Muenchen, Germany, 81675
        • Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen
      • Munich, Germany, 80637
        • Rotkreuzklinikum Munchen, Frauenklinik,
      • Munich, Germany, 81377
        • Breast Cancer, University of Munich, Grosshadern Hospital
      • Trier, Germany, 54290
        • Klinikum Mutterhaus
    • Bavaria
      • Muenchen, Bavaria, Germany, 80336
        • IOZ- Munchen, PGM- Studien GmbH
  • Hungary
      • Budapest, Hungary, 1032
        • Szent Margit Kórház
      • Budapest, Hungary, 1054
        • Affidea Diagnosztika Kft.
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet ,
      • Budapest, Hungary, H-1122
        • Országos Onkológiai Intézet "B" Belgyogyaszati osztaly
      • Budapest, Hungary, H-1122
        • Országos Onkológiai Intézet, Nuklearis Medicina Osztaly
      • Budapest, Hungary, H-1122
        • Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily
      • Györ, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Teaching Hospital,
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar
      • Szeged, Hungary, 6725
        • Diagnoscan Magyarorszag Kft.
  • Ireland
      • Cork, Ireland
        • Bon Secours Hospital
      • Dublin, Ireland, 8
        • St. James Hospital
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, Dublin 7
        • Mater Misericordiae University Hospital
      • Dublin 4, Ireland
        • St Vincents University Hospital
      • Galway, Ireland
        • Department of Medical Oncology
      • Limerick, Ireland
        • Mid Western Regional Hospital
      • Waterford, Ireland
        • Waterford Regional Hospital
  • Italy
      • Avellino, Italy, 83100
        • Azienda Ospedaliera San Giuseppe Moscati
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Roma, Italy, 00128
        • Istituti Fisioterapici Ospitalieri
      • Sora (FR), Italy, 03039
        • Ospedale SS Trinità
    • BO
      • Bologna, BO, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
    • FC
      • Meldola, FC, Italy, 47014
        • Irccs Irst
    • Milan
      • Milano, Milan, Italy, 20141
        • IRCCS - Istituto Europeo di Oncologia
  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
      • Kagoshima, Japan, 892-0833
        • Hakuaikai Medical Corporation Sagara Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital 2-15-3
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama-city, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-8505
        • Kumamoto City Hospital
    • Saitama
      • Kita-adachi-gun, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital / Department of Internal Medicine
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center, Division of Oncology, Department of Internal Medicine
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center, Center for Breast Cancer
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Seoul
      • Seodaemun-gu, Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
  • Poland
      • Gdańsk, Poland, 80-214
        • Oncology and Radiotherapy Clinic
      • Zory, Poland, 44-240
        • Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian
    • Mazovia
      • Otwock, Mazovia, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan
      • Moscow, Russian Federation, 115478
        • Federal State Budget Institution
      • Moscow Area, Russian Federation, 143423
        • State Budget Healthcare Institution Moscow City Oncology Hospital
      • Omsk, Russian Federation, 644013
        • Budget Institution of Healthcare
      • Omsk, Russian Federation, 644046
        • Budget Institution of Healthcare
      • Ryazan, Russian Federation, 390011
        • Ryazan Regional clinical oncology dispensary
      • Saint-Petersburg, Russian Federation, 198255
        • Saint-Petersburg State Budget Healthcare Institution (SBHCI)
      • St Petersburg, Russian Federation, 195271
        • Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways
      • Ufa, Russian Federation, 450005
        • Republican Clinical Hospital n.a. G.G. Kuvatov
      • Ufa, Russian Federation, 450054
        • State Budget Medical Institution Republican Clinical Oncology
      • Ufa, Russian Federation, 450106
        • SBHI of Republic of Bashkortostan Emergency Hospital
    • Kursk Region
      • Kursk, Kursk Region, Russian Federation, 305524
        • Regional Budgetary Healthcare Institution Kursk Regional Clinical
    • Leningrad Region
      • Kuzmolovo, Leningrad Region, Russian Federation, 188663
        • State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"
  • Spain
      • Badajoz, Spain, 06080
        • Hospital Universitario Infanta Cristina
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Donostia- San Sebastian, Spain, 20014
        • Hospital de Donostia
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaén
      • L'Hospitalet De Llobregat (Barcelona), Spain, 08908
        • Instituto Catalán de Oncología L'Hospitalet
      • La Coruna, Spain, 15009
        • Centro Oncologico de Galicia
      • Lleida, Spain, 25198
        • Hospital Universitario Arnau de Vilanova de Lleida
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28033
        • Centro Oncologico MD ANDERSON Internacional Espana
      • Madrid, Spain, 28050
        • Hospital Madrid Universitario Sanchinarro
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Universitari Son Espases
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundacion de Alcorcon
    • Santa CRUZ DE Tenerife
      • La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
  • Taiwan
      • Taipei, Taiwan, 10449
        • Mackay Memory Hospital
      • Taipei City, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 11217
        • Veterans General Hospital-Taipei
  • Ukraine
      • Dnipro, Ukraine, 49102
        • MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council
      • Dnipro, Ukraine, 49102
        • State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine
      • Kharkiv, Ukraine, 61070
        • Municipal Non-profit Enterprise "Regional Centre of Oncology"
      • Lviv, Ukraine, 79031
        • Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department
      • Makiivka, Ukraine, 86120
        • Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"
      • Sumy, Ukraine, 40005
        • Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
      • Uzhgorod, Ukraine, 88000
        • City Oncology Centre of Central Municipal Clinical Hospital
      • Uzhgorod, Ukraine, 88000
        • Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.
      • Zaporizhzhia, Ukraine, 69040
        • MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,
      • Zaporizhzhya, Ukraine, 69040
        • State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • London, United Kingdom, SE1 9RT
        • Guys Hospital
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital NHS Foundation Trust
      • Manchester, United Kingdom, M204BX
        • The Research And Development Office, The Christie NHS Foundation Trust
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Kent Oncology Center
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre, Western General Hospital
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Beatson Institute for Cancer Research
  • United States
    • California
      • Bellflower, California, United States, 90706
        • Southern California Permanente Medical Group
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Fullerton, California, United States, 92835
        • St. Joseph Heritage Healthcare
      • Glendale, California, United States, 91206
        • Los Angeles Hematology/Oncology Medical Group
      • Irvine, California, United States, 92604
        • UCLA Hematology/ Oncology- Irvine
      • Laguna Hills, California, United States, 92653
        • UCLA Hematology Oncology- Laguna Hills
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology
      • Los Angeles, California, United States, 90017
        • Los Angeles Hematology/Oncology Medical Group
      • Los Angeles, California, United States, 90027
        • Southern California Permanente Medical Group
      • Los Angeles, California, United States, 90045
        • Translational Research Management
      • Los Angeles, California, United States, 90095-1772
        • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
      • Los Angeles, California, United States, 90095-7349
        • UCLA West Medical Pharmacy, Attn: Steven L. Wong
      • Los Angeles, California, United States, 90095-7349
        • UCLA West Medical Pharmacy: Drug Management Only
      • Los Angeles, California, United States, 90095-7349
        • UCLA West Medical Pharmacy; Drug Management Only
      • Los Angeles, California, United States, 90095-7349
        • UCLA West Medical Pharmacy
      • Los Angeles, California, United States, 90095
        • Administrative Address: UCLA Hematology/Oncology
      • Los Angeles, California, United States, 90095
        • Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.
      • Los Angeles, California, United States, 90095
        • Regulatory Management Only: TRIO-US Central Administration
      • Los Angeles, California, United States, 90095
        • TRIO-US Central Administration: Regulatory Management Only
      • Los Angeles, California, United States, 90095
        • TRIO-US Central Administration
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology
      • Pasadena, California, United States, 91105
        • UCLA Hematology/ Oncology- Pasadena
      • Redondo Beach, California, United States, 90277
        • Torrance Health Association, DBa Torrance Memorial Physician Network
      • San Diego, California, United States, 92108
        • Southern California Permanente Medical Group
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
      • San Francisco, California, United States, 94158
        • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
      • San Luis Obispo, California, United States, 93401
        • San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, United States, 90404
        • UCLA Santa Monica Medical Center and Orthopaedic Hospital
      • Stanford, California, United States, 94304-5826
        • Stanford Women's Cancer Center
      • West Hills, California, United States, 91307
        • Wellness Oncology & Hematology
      • Westlake Village, California, United States, 91361
        • UCLA Hematology/Oncology- Westlake
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary'S Hospital Regional Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Smilow Cancer Hospital at Yale New Haven
      • Norwalk, Connecticut, United States, 06856
        • Whittingham Cancer Center @ Norwalk Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • Sylvester at Deerfield Beach
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Breast Cancer Center at Memorial Regional Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialist of North Florida, Pharmacy
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida-Southpoint
      • Orlando, Florida, United States, 32806
        • Orlando Health, Inc.
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Cancer Institute at Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital West
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Breast Cancer Center at Memorial Hospital West
      • Plantation, Florida, United States, 33324
        • Sylvester Comprehensive Cancer Center Plantation
      • Saint Augustine, Florida, United States, 32086
        • Cancer Specialists Of North Florida - St. Augustine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30303
        • Grady Health System
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Clinic Cancer Services
      • Post Falls, Idaho, United States, 83854
        • Kootenai Clinic Cancer Services
    • Illinois
      • Chicago, Illinois, United States, 60657
        • The Mark M. Connolly Center for Cancer and Specialty Care
      • Danville, Illinois, United States, 61832
        • Carle Foundation Hospital dba Carle Cancer Center
      • Effingham, Illinois, United States, 62401
        • Carle Foundation Hospital dba Carle Cancer Center
      • Evanston, Illinois, United States, 60202
        • Presence Infusion Care- Evanston
      • Mattoon, Illinois, United States, 61938
        • Carle Foundation Hospital dba Carle Cancer Center
      • Skokie, Illinois, United States, 60077
        • Presence Infusion Care- Skokie
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital dba Carle Cancer Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center and University Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Cancer Center
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Frauenshuh Cancer Center
    • Mississippi
      • Corinth, Mississippi, United States, 38834
        • The West Clinic, PC
      • Southaven, Mississippi, United States, 38671
        • The West Clinic, PC dba West Cancer Centre
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Clinic St. Louis Cancer and Breast Institute
      • Saint Louis, Missouri, United States, 63109
        • Mercy Clinic St. Louis Cancer and Breast Institute
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis - David C. Pratt Cancer Center
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
    • Nebraska
      • Grand Island, Nebraska, United States, 68802
        • Saint Francis Medical Center
      • Grand Island, Nebraska, United States, 68803
        • Saint Francis Medical Center, Saint Francis Cancer Treatment Center
      • Hastings, Nebraska, United States, 68901
        • Saint Francis Medical Center
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, United States, 89074-8195
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89119
        • Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • Brewster, New York, United States, 10509
        • CareMount Medical
      • Mount Kisco, New York, United States, 10549
        • CareMount Medical
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Stony Brook, New York, United States, 11794-9447
        • Stony Brook University- Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97239
        • OHSU Center for Health and Healing 2
      • Portland, Oregon, United States, 97239
        • OHSU Center for Health and Healing
      • Portland, Oregon, United States, 97239
        • OHSU Research Pharmacy Services
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialists, PC
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest Region
      • Portland, Oregon, United States, 97227
        • Northwest Cancer Specialists, P.C.
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • Tennessee Oncology, PLLC
      • Franklin, Tennessee, United States, 37067
        • Tennessee Oncology PLLC
      • Gallatin, Tennessee, United States, 37066
        • Tennessee Oncology, PLLC
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, PC dba West Cancer Centre
      • Hermitage, Tennessee, United States, 37076
        • Tennessee Oncology PLLC
      • Lebanon, Tennessee, United States, 37090
        • Tennessee Oncology, PLLC
      • Memphis, Tennessee, United States, 38104
        • The West Clinic, PC dba West Cancer Centre
      • Murfreesboro, Tennessee, United States, 37129
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37205
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37207
        • Tennessee Oncology PLLC
      • Nashville, Tennessee, United States, 37211
        • Tennessee Oncology PLLC
      • Shelbyville, Tennessee, United States, 37160
        • Tennessee Oncology, PLLC
      • Smyrna, Tennessee, United States, 37167
        • Tennessee Oncology PLLC
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75231
        • Texas Oncology-Dallas Presbyterian Hospital
      • El Paso, Texas, United States, 79902
        • Texas Oncology-West Texas
      • El Paso, Texas, United States, 79915
        • Texas Oncology-West Texas
      • El Paso, Texas, United States, 79938
        • Texas Oncology-West Texas
      • Fort Worth, Texas, United States, 76177
        • Investigational Products Center (IPC)
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center.
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Products Center
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
      • Low Moor, Virginia, United States, 24457
        • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
      • Salem, Virginia, United States, 24153
        • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
      • Wytheville, Virginia, United States, 24382
        • Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Vancouver, Washington, United States, 98683
        • Northwest Cancer Specialists, P.C.
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists P.C.
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • WVU Medicine
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
  • Confirmed diagnosis of ER positive breast cancer
  • No prior systemic anti-cancer therapy for advanced ER+ disease.
  • Postmenopausal women
  • Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease
  • Eastern Cooperative Oncology Group [ECOG] 0-2
  • Adequate organ and marrow function
  • Patient must agree to provide tumor tissue

Exclusion Criteria:

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-0332991 + Letrozole
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Drug: PD-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Active Comparator: Placebo + Letrozole
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Drug: Placebo
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS) as Assessed by the Investigator
Time Frame: From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)
PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.
From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
Time Frame: From Baseline up to 2.5 years
The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).
From Baseline up to 2.5 years
Survival Probability at 1 Year, 2 Year and 3 Year
Time Frame: 1, 2 and 3 years after randomization
One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.
1, 2 and 3 years after randomization
Objective Response as Assessed by the Investigator
Time Frame: From randomization until end of treatment (up to approximately 2.5 years)
Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
From randomization until end of treatment (up to approximately 2.5 years)
Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator
Time Frame: From randomization until end of treatment (up to approximately 2.5 years)
The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
From randomization until end of treatment (up to approximately 2.5 years)
Duration of Response (DR)
Time Frame: From randomization until end of treatment (up to approximately 2.5 years)
DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
From randomization until end of treatment (up to approximately 2.5 years)
Disease Control (DC)/Clinical Benefit Response (CBR)
Time Frame: From randomization until end of treatment (up to approximately 2.5 years)
DC is defined as overall CR, PR, or stable disease (SD) >=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD >=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.
From randomization until end of treatment (up to approximately 2.5 years)
PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
Time Frame: From randomization until end of treatment (up to approximately 24 Months)
PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score >=1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.
From randomization until end of treatment (up to approximately 24 Months)
Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14
Time Frame: Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.
Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14
Percentage of Participants With Corrected QT Interval (QTc)
Time Frame: For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.
For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)
Observed Plasma Trough Concentration (Ctrough) at Steady-State
Time Frame: 0 hour (predose) on Day 14 of cycles 1 and 2
Summary of plasma palbociclib within-participant mean steady-state trough concentrations.
0 hour (predose) on Day 14 of cycles 1 and 2
Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time Frame: From Baseline up to 2.5 years
FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.
From Baseline up to 2.5 years
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities
Time Frame: From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)
An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.
From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)
Overall Survival (OS): Primary Analysis
Time Frame: From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at primary analysis.
From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)
Overall Survival (OS): Final Analysis
Time Frame: From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)
OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.
From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)
Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade
Time Frame: From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)
Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.
From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2013

Primary Completion (Actual)

February 26, 2016

Study Completion (Actual)

November 9, 2023

Study Registration Dates

First Submitted

November 26, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimated)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481008
  • 2012-004601-27 (EudraCT Number)
  • PALMOA-2 (Other Identifier: Alias Study Number)
  • PALOMA-2 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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