Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

April 1, 2024 updated by: Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

521

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
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown - Lidcombe Hospital
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • River City Pharmacy
      • Nambour, Queensland, Australia, 4560
        • Sunshine Coast Hospital and Health Service
      • Southport, Queensland, Australia, 4215
        • Icon Cancer Care Southport
    • Victoria
      • Brighton, Victoria, Australia, 3186
        • Cabrini Brighton
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Frankston, Victoria, Australia, 3199
        • Peninsula and Southeast Oncology
      • Geelong, Victoria, Australia, 3220
        • Barwon Health, University Hospital Geelong
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre Pharmacy
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital
      • St Albans, Victoria, Australia, 3021
        • Sunshine Hospital Clinical Trials Pharmacy
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital - Cancer Centre
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imelda Ziekenhuis
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-luc
      • Leuven, Belgium, 3000
        • UZ Leuven - Campus Gasthuisberg
      • Namur, Belgium, 5000
        • CHU Ucl Namur - Site Sainte-Elisabeth
      • Wilrijk, Belgium, 2610
        • GZA Ziekenhuizen - Campus St Augustinus
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Clinique Saint-Pierre
    • Bruxelles Capitale
      • Bruxelles, Bruxelles Capitale, Belgium, 1000
        • Institut Jules Bordet
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6000
        • Grand Hopital de Charleroi - Site Notre Dame
      • Haine St. Paul, Hainaut, Belgium, 7100
        • INDC Entité Jolimontoise - CH de Jolimont-Lobbes
      • Tournai, Hainaut, Belgium, 7500
        • CHWaPi - Site IMC
    • Luxembourg
      • Libramont-Chevigny, Luxembourg, Belgium, 6800
        • C.H. de l'Ardenne - site Libramont
    • Region DE Bruxelles-capital
      • Bruxelles, Region DE Bruxelles-capital, Belgium, 1070
        • Hopital Erasme
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
      • Surrey, British Columbia, Canada, V3V 1Z2
        • British Columbia Cancer Agency - Fraser Valley Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Kingston, Ontario, Canada, K7L 2V7
        • Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Centre, General Campus
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Niagara Health System Walker Family Cancer Center
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Germany
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig AoeR
      • Leipzig, Germany, 04103
        • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz
      • München, Germany, 80336
        • Klinikum der Universität München
      • München, Germany, 80337
        • Klinikum der Universität München
  • Ireland
      • Cork, Ireland
        • Bon Secours Hospital
  • Italy
      • Bagno A Ripoli (FI), Italy, 50012
        • Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna
      • Bagno A Ripoli (FI), Italy, 50012
        • S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata
      • Bologna, Italy, 40138
        • SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi
      • Catania, Italy, 95123
        • U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"
      • Legnago (VR), Italy, 37045
        • Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis
      • Legnago (VR), Italy, 37045
        • Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago
      • Meldola (FC), Italy, 47014
        • IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
      • Milano, Italy, 20132
        • IRCCS Ospedale S. Raffaele
      • Milano, Italy, 20132
        • Farmacia IRCCS Ospedale San Raffaele
      • Milano, Italy, 20141
        • Servizio di Farmacia - Istituto Europeo di Oncologia
      • Modena, Italy, 41124
        • Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,
      • Napoli, Italy, 80131
        • IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli
      • Roma, Italy, 00168
        • Farmacia - Fondazione Policlinico Universitario A. Gemelli
      • Terni, Italy, 05100
        • S.C. Oncologia, A.O.S. Maria
  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Kagoshima, Japan, 892-0833
        • Hakuaikai Medical Corporation Sagara Hospital
      • Osaka, Japan, 540-0006
        • National Hospital Organization
    • 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
    • Saitama,japan
      • Kita-adachi-gun, Saitama,japan, Japan, 362-0806
        • Saitama Cancer Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht
      • Sittard-Geleen, Limburg, Netherlands, 6162 BG
        • Orbis Medisch Centrum
    • Noord-brabant
      • Tilburg, Noord-brabant, Netherlands, 5042AD
        • TweeSteden Ziekenhuis
    • Zuid-holland
      • Den Haag, Zuid-holland, Netherlands, 2545 AA
        • Haga ziekenhuis
      • Leiden, Zuid-holland, Netherlands, 2333ZA
        • Leids Universitair Medisch Centrum
      • Rotterdam, Zuid-holland, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
  • Portugal
      • Lisboa, Portugal, 1400-038
        • Champalimaud Cancer Center/ Breast Unit
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia
  • Romania
      • Bucharest, Romania, 011464
        • Spitalul Clinic CF nr.2 Bucuresti
      • Ploiesti, Romania, 100337
        • Spitalul Municipal Ploiesti
      • Suceava, Romania, 720237
        • Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
      • Tg. Mures, Romania, 540142
        • Spitalul Clinic Judetean Mures
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine
      • Moscow, Russian Federation, 115478
        • FSBSI Russian Cancer Research Center n.a.NN Blokhin
      • Saint Petersburg, Russian Federation, 197022
        • Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
      • Saint Petersburg, Russian Federation, 198255
        • Saint Petersburg GBUZ City Clinical Oncology Dispensary
      • Stavropol, Russian Federation, 355047
        • GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
      • Village Pesochny, Russian Federation, 197758
        • FGBU Russian Research Center for Radiology and Surgical Technologies
    • Belgorodskaya Oblast'
      • Stariy Oskol, Belgorodskaya Oblast', Russian Federation, 309504
        • OGBUZ Belgorod Oncology Dispensary
    • Belgorodskaya Oblast',
      • Belgorod,, Belgorodskaya Oblast',, Russian Federation, 308010
        • OGBUZ Belgorod Oncology Dispensary
    • Leningradskaya Oblast'
      • Village Kuzmolovsky, Leningradskaya Oblast', Russian Federation, 188663
        • GBUZ Leningrad regional oncological dispensary
    • Republic OF Bashkortostan
      • Ufa, Republic OF Bashkortostan, Russian Federation, 450054
        • GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
    • Stavropol Territory
      • Lermontov, Stavropol Territory, Russian Federation, 357340
        • FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
      • Pyatigorsk,, Stavropol Territory, Russian Federation, 357502
        • GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
  • Taiwan
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35040
        • Ege University Medical Faculty
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"
      • Dnipro, Ukraine, 49102
        • Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,
      • Kharkiv, Ukraine, 61070
        • Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi
      • Lviv, Ukraine, 79031
        • KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi
      • Odesa, Ukraine, 65025
        • Komunalna ustanova "Odeska oblasna klinichna likarnia"
      • Vinnytsia, Ukraine, 21029
        • Podilskyi rehionalnyi tsentr onkolohii,
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • The Royal Marsden NHS Foundation Trust
      • Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre
    • South Glamorgan
      • Cardiff, South Glamorgan, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
        • Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham, The Kirklin Clinic
      • Birmingham, Alabama, United States, 35249
        • UAB Hospital-Investigational Drug Service
      • Daphne, Alabama, United States, 36526
        • Southern Cancer Center, PC
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center, PC
      • Mobile, Alabama, United States, 36607
        • Southern Cancer Center, PC
      • Mobile, Alabama, United States, 36608
        • Southern Cancer Center,PC
    • Arizona
      • Avondale, Arizona, United States, 85323
        • Arizona Center for Cancer Care
      • Chandler, Arizona, United States, 85224
        • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
      • Flagstaff, Arizona, United States, 86001
        • Arizona Oncology Associates, PC- HAL
      • Gilbert, Arizona, United States, 85297
        • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
      • Glendale, Arizona, United States, 85306
        • Arizona Center for Cancer Care
      • Glendale, Arizona, United States, 85304
        • Palo Verde Hematology Oncology
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center, Inc.
      • Mesa, Arizona, United States, 85202
        • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
      • Mesa, Arizona, United States, 85206
        • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
      • Prescott Valley, Arizona, United States, 86314
        • Arizona Oncology Associates, PC- HAL
      • Sedona, Arizona, United States, 86336
        • Arizona Oncology Associates, PC- HAL
      • Surprise, Arizona, United States, 85374
        • Arizona Center for Cancer Care
      • Tucson, Arizona, United States, 85724
        • The University of Arizona Cancer Center
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center- North Campus
    • California
      • Bakersfield, California, United States, 93309
        • CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
      • Culver City, California, United States, 90232
        • Administrative Management Only: Translational Research Management
      • Duarte, California, United States, 91010
        • City of Hope
      • Fullerton, California, United States, 92835
        • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
      • Glendale, California, United States, 91204
        • Global Research Management
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • La Jolla, California, United States, 92037
        • UC San Diego Medical Center-La Jolla
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90033
        • LAC & USC Medical Center
      • Orange, California, United States, 92868
        • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
      • Orange, California, United States, 92868
        • Breastlink Medical Group, Inc.
      • Orange, California, United States, 92868
        • Hematology Oncology Medical Group of Orange County, Inc. (HOMG)
      • Pasadena, California, United States, 91105
        • UCLA Hematology/Oncology - Pasadena
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center-Hillcrest
      • San Francisco, California, United States, 94115
        • University of California, San Francisco: Helen Diller Comprehensive Cancer Center
      • San Luis Obispo, California, United States, 93401
        • San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
      • Santa Ana, California, United States, 92705
        • Breastlink Medical Group, Inc.
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, United States, 90404
        • UCLA Hematology/Oncology - Santa Monica
      • South Pasadena, California, United States, 91030
        • City of Hope
      • Torrance, California, United States, 90505
        • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates
      • Torrance, California, United States, 90505
        • Torrance Memorial Physician Network-Cancer Care
      • West Hills, California, United States, 91307
        • Wellness Oncology & Hematology
      • Westlake Village, California, United States, 91361
        • UCLA Hematology - Oncology Clinic - Westlake Village
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
      • Aurora, Colorado, United States, 80045
        • ATTN - Research Pharmacist
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
    • Florida
      • Aventura, Florida, United States, 33180
        • Mount Sinai Medical Center- Aventura
      • Deerfield Beach, Florida, United States, 33442
        • Sylvester Comprehensive Cancer Center Deerfield Beach
      • Deerfield Beach, Florida, United States, 33442
        • University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center
      • 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
      • Miami, Florida, United States, 33136
        • University of Miami Hospitals & Clinics
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Ocoee, Florida, United States, 34761
        • Orlando Health
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
      • 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 at Plantation
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, PC
      • Austell, Georgia, United States, 30106
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
      • Cartersville, Georgia, United States, 30121
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Cancer Institute, PC
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Zion, Illinois, United States, 60099
        • Cancer Treatment Centers of America at Midwestern Regional Medical center
    • Maine
      • Brunswick, Maine, United States, 04011
        • Maine Center for Cancer Medicine, dba: New England Cancer Specialists
      • Kennebunk, Maine, United States, 04043
        • Maine Center for Cancer Medicine, dba: New England Cancer Specialists
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine, dba: New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
      • Lutherville, Maryland, United States, 21093
        • Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System/Comprehensive Cancer Center
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Oncology Clinic
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Physicians, Masonic Cancer Center
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Mercy Clinic St. Louis Cancer and Breast Institute
      • Chesterfield, Missouri, United States, 63017
        • Mercy Ministry Office
      • Saint Louis, Missouri, United States, 63109
        • Mercy Clinic St. Louis Cancer and Breast Institute
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St.Louis- David C. Pratt Cancer Center
    • Nevada
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Brewster, New York, United States, 10509
        • CareMount Medical
      • Lake Success, New York, United States, 11042
        • ProHEALTHCARE Associates, LLP
      • Mount Kisco, New York, United States, 10549
        • CareMount Medical
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Hope Women's Cancer Centers
      • Asheville, North Carolina, United States, 28806
        • Mission Hospital, Inc.
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC Cancer Center, Monroeville
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Womens Hospital of UPMC
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Oncology- Dallas Presbyterian Hospital
      • Fort Worth, Texas, United States, 76177
        • Investigational Products Center (IPC)
      • Irving, Texas, United States, 75063
        • US Oncology Investigational Products Center (IPC)
      • Irving, Texas, United States, 75063
        • US Oncology lnvestigational Products Center (IPC)
      • Longview, Texas, United States, 75601
        • Texas Oncology- Longview Cancer Center
      • McAllen, Texas, United States, 78503
        • Texas Oncology- McAllen South Second Street
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78212
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78258
        • Cancer Care Centers of South Texas
      • Tyler, Texas, United States, 75702
        • Texas Oncology- Tyler
      • Weslaco, Texas, United States, 78596
        • Texas Oncology- Weslaco
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Virginia Cancer Specialists, PC
      • Charlottesville, Virginia, United States, 22903
        • Emily Couric Clinical Cancer Center
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fairfax, Virginia, United States, 22031
        • Inova Medical Group
      • Leesburg, Virginia, United States, 20176
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology, P.C.
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center First Hill IDS Pharmacy
    • Wisconsin
      • Mequon, Wisconsin, United States, 53097
        • Columbia St. Mary's
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia St. Mary's

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Drug: Palbociclib
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Drug: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Active Comparator: Arm B
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Drug: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Drug: Placebo
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.

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 (assessed up to 12 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
From Cycle 1 to 14, as of 05 December 2014.
Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
From Cycle 1 to 14, as of 05 December 2014.
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
From Cycle 1 to 14, as of 05 December 2014.
Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.
From Cycle 1 to 14, as of 05 December 2014.
Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
From Cycle 1 to 14, as of 05 December 2014.
Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale
Time Frame: From Cycle 1 to 14, as of 05 December 2014.
The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
From Cycle 1 to 14, as of 05 December 2014.
Overall Survival (OS)-Number of Participants Who Died
Time Frame: From randomization until death (up to 4.5 years)
OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) - randomization date + 1]/30.4.
From randomization until death (up to 4.5 years)
Overall Survival (OS)
Time Frame: From randomization until death (up to 4.5 years)
OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) - randomization date + 1]/30.4.
From randomization until death (up to 4.5 years)
Survival Probabilities at Year 1, Year 2, and Year 3
Time Frame: From randomization until death (assessed up to 36 months)
One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.
From randomization until death (assessed up to 36 months)
Objective Response (OR)
Time Frame: From randomization until end of treatment (assessed up to 2 years)
OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.
From randomization until end of treatment (assessed up to 2 years)
Duration of Response (DR)
Time Frame: From randomization until end of treatment (assessed up to 2 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 was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.
From randomization until end of treatment (assessed up to 2 years)
Clinical Benefit Response (CBR)
Time Frame: From randomization until end of treatment (assessed up to 2 years)
CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
From randomization until end of treatment (assessed up to 2 years)
Observed Plasma Trough Concentration (Ctrough) for Palbociclib
Time Frame: Cycle 1/Day 15 and Cycle 2/Day 15
Ctrough was defined as steady-state predose concentration. Observed directly from data. For palbociclib, a steady-state trough was to be defined as a predose plasma concentration following at least 8 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 22 and 26 hours after the dose (the day prior to PK collection) and no more than 1 hour post-dose on the day of PK collection.
Cycle 1/Day 15 and Cycle 2/Day 15
Ctrough for Fulvestrant
Time Frame: Cycles 2/Day 1 and Cycle 3/Day 1
Ctrough was defined as steady-state predose concentration. Observed directly from data. For fulvestrant, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
Cycles 2/Day 1 and Cycle 3/Day 1
Ctrough for Goserelin
Time Frame: Cycles 2/ Day 1 and Cycle 3/ Day 1
Ctrough was defined as steady-state predose concentration. Observed directly from data. For goserelin, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.
Cycles 2/ Day 1 and Cycle 3/ Day 1
Time to Deterioration (TTD)
Time Frame: Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment, as of 05 December 2014
A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.
Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment, as of 05 December 2014
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)
Time Frame: From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.
From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).
Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results
Time Frame: From baseline to end of treatment/withdrawal (up to 4.5 years)
Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters Anemia, Hemoglobin increased, Neutrophil count decreased, Platelet count decreased, and White blood cell count decreased) were reported.
From baseline to end of treatment/withdrawal (up to 4.5 years)
Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results
Time Frame: From baseline to end of treatment/withdrawal (up to 4.5 years)
Number of participants with shifts from Grade ≤2 at baseline values to post-baseline values (shift to Grade 3 or 4) were reported as per NCI-CTCAE, V4.0 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Shifts in lab parameter from Grade ≤2 at baseline to Grade 3 or 4 postbaseline (for parameters ALT increased, ALP increased, AST increased, Blood bilirubin increased, Creatinine increased, Hypercalcemia, Hyperkalemia, Hypermagnesemia, Hypernatremia, Hypoalbuminemia, Hypocalcemia, Hypokalemia, Hypomagnesemia, and Hyponatremia) were reported.
From baseline to end of treatment/withdrawal (up to 4.5 years)

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

AstraZeneca

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)

September 26, 2013

Primary Completion (Actual)

December 5, 2014

Study Completion (Actual)

September 28, 2022

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimated)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5481023
  • 2013-002580-26 (EudraCT 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.

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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