AzTrials
AzTrials

Metastatic Breast CancerPhase 3NCT01942135

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

A Phase 3 study testing Palbociclib and Fulvestrant in people with Metastatic Breast Cancer, run by Pfizer at 247 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Palbociclib and Fulvestrant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
521 participants
Where
247 sitesin 17 countries
Study dates
26 Sep 2013to 28 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

247 sites in 17 countries.

247 sites in 17 countries

United States134 sites

  • University of Michigan Health System/Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205

  • Hope Women's Cancer Centers

    Asheville, North Carolina, 28806

  • Mission Hospital, Inc.

    Asheville, North Carolina, 28806

  • Piedmont Cancer Institute, PC

    Atlanta, Georgia, 30318

  • ATTN - Research Pharmacist

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Austell, Georgia, 30106

  • Mount Sinai Medical Center- Aventura

    Aventura, Florida, 33180

  • Arizona Center for Cancer Care

    Avondale, Arizona, 85323

  • CBCC Global Research Inc. at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Mercy Clinic St. Louis Cancer and Breast Institute

    Ballwin, Missouri, 63011

  • Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins

    Baltimore, Maryland, 21231

  • University of Alabama at Birmingham, The Kirklin Clinic

    Birmingham, Alabama, 35233

  • UAB Hospital-Investigational Drug Service

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • CareMount Medical

    Brewster, New York, 10509

  • Maine Center for Cancer Medicine, dba: New England Cancer Specialists

    Brunswick, Maine, 04011

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Cartersville, Georgia, 30121

  • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Emily Couric Clinical Cancer Center

    Charlottesville, Virginia, 22903

  • Mercy Ministry Office

    Chesterfield, Missouri, 63017

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Administrative Management Only: Translational Research Management

    Culver City, California, 90232

  • Texas Oncology- Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Southern Cancer Center, PC

    Daphne, Alabama, 36526

  • Sylvester Comprehensive Cancer Center Deerfield Beach

    Deerfield Beach, Florida, 33442

  • University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • City of Hope

    Duarte, California, 91010

  • Fairview Southdale Oncology Clinic

    Edina, Minnesota, 55435

  • Inova Medical Group

    Fairfax, Virginia, 22031

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Piedmont Cancer Institute, PC

    Fayetteville, Georgia, 30214

  • Arizona Oncology Associates, PC- HAL

    Flagstaff, Arizona, 86001

  • Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • Investigational Products Center (IPC)

    Fort Worth, Texas, 76177

  • St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers

    Gilbert, Arizona, 85297

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

  • Arizona Center for Cancer Care

    Glendale, Arizona, 85306

  • Global Research Management

    Glendale, California, 91204

  • Western Regional Medical Center, Inc.

    Goodyear, Arizona, 85338

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • Memorial Breast Cancer Center at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas, 75063

  • US Oncology lnvestigational Products Center (IPC)

    Irving, Texas, 75063

  • Maine Center for Cancer Medicine, dba: New England Cancer Specialists

    Kennebunk, Maine, 04043

  • UC San Diego Medical Center-La Jolla

    La Jolla, California, 92037

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • ProHEALTHCARE Associates, LLP

    Lake Success, New York, 11042

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • Texas Oncology- Longview Cancer Center

    Longview, Texas, 75601

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • LAC & USC Medical Center

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

  • Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station

    Lutherville, Maryland, 21093

  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

    Marietta, Georgia, 30060

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Texas Oncology- McAllen South Second Street

    McAllen, Texas, 78503

  • Columbia St. Mary's

    Mequon, Wisconsin, 53097

  • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers

    Mesa, Arizona, 85202

  • Ironwood Physicians P.C dba Ironwood Cancer & Research Centers

    Mesa, Arizona, 85206

  • University of Miami Hospitals & Clinics

    Miami, Florida, 33136

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Columbia St. Mary's

    Milwaukee, Wisconsin, 53211

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • University of Minnesota Physicians, Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Southern Cancer Center, PC

    Mobile, Alabama, 36607

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • Southern Cancer Center,PC

    Mobile, Alabama, 36608

  • UPMC Cancer Center, Monroeville

    Monroeville, Pennsylvania, 15146

  • CareMount Medical

    Mount Kisco, New York, 10549

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Orlando Health

    Ocoee, Florida, 34761

  • Breastlink Medical Group, Inc.

    Orange, California, 92868

  • Hematology Oncology Medical Group of Orange County, Inc. (HOMG)

    Orange, California, 92868

  • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • UCLA Hematology/Oncology - Pasadena

    Pasadena, California, 91105

  • Memorial Breast Cancer Center at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Memorial Hospital West

    Pembroke Pines, Florida, 33028

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Sylvester at Plantation

    Plantation, Florida, 33324

  • Arizona Oncology Associates, PC- HAL

    Prescott Valley, Arizona, 86314

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78212

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78258

  • UC San Diego Medical Center-Hillcrest

    San Diego, California, 92103

  • University of California, San Francisco: Helen Diller Comprehensive Cancer Center

    San Francisco, California, 94115

  • San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers

    San Luis Obispo, California, 93401

  • Breastlink Medical Group, Inc.

    Santa Ana, California, 92705

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • Maine Center for Cancer Medicine, dba: New England Cancer Specialists

    Scarborough, Maine, 04074

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Swedish Medical Center First Hill IDS Pharmacy

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98122

  • Arizona Oncology Associates, PC- HAL

    Sedona, Arizona, 86336

  • City of Hope

    South Pasadena, California, 91030

  • Mercy Clinic St. Louis Cancer and Breast Institute

    St Louis, Missouri, 63109

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Mercy Hospital St.Louis- David C. Pratt Cancer Center

    St Louis, Missouri, 63141

  • Arizona Center for Cancer Care

    Surprise, Arizona, 85374

  • Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

    Torrance, California, 90505

  • Torrance Memorial Physician Network-Cancer Care

    Torrance, California, 90505

  • The University of Arizona Cancer Center- North Campus

    Tucson, Arizona, 85719

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Texas Oncology- Tyler

    Tyler, Texas, 75702

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Texas Oncology- Weslaco

    Weslaco, Texas, 78596

  • Wellness Oncology & Hematology

    West Hills, California, 91307

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village, California, 91361

  • Shenandoah Oncology, P.C.

    Winchester, Virginia, 22601

  • Cancer Treatment Centers of America at Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Italy17 sites

  • Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna

    Bagno A Ripoli (FI), 50012

  • S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata

    Bagno A Ripoli (FI), 50012

  • SSD Oncologia Medica Addarii-Zamagni A.O.U. di Bologna Policlinico S. Orsola Malpighi

    Bologna, 40138

  • U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"

    Catania, 95123

  • Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis

    Legnago (VR), 37045

  • Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago

    Legnago (VR), 37045

  • IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola (FC), 47014

  • Farmacia IRCCS Ospedale San Raffaele

    Milan, 20132

  • IRCCS Ospedale S. Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Servizio di Farmacia - Istituto Europeo di Oncologia

    Milan, 20141

  • Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,

    Modena, 41124

  • IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori

    Naples, 80131

  • Farmacia - Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, 00168

  • S.C. Oncologia, A.O.S. Maria

    Terni, 05100

Other trials in Italy

Australia15 sites

  • River City Pharmacy

    Auchenflower, Queensland, 4066

  • Bankstown - Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Cabrini Brighton

    Brighton, Victoria, 3186

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Peninsula and Southeast Oncology

    Frankston, Victoria, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre Pharmacy

    Melbourne, Victoria, 3000

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital - Cancer Centre

    Murdoch, Western Australia, 6150

  • Sunshine Coast Hospital and Health Service

    Nambour, Queensland, 4560

  • Icon Cancer Care Southport

    Southport, Queensland, 4215

  • Sunshine Hospital Clinical Trials Pharmacy

    St Albans, Victoria, 3021

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

Belgium13 sites

  • Imelda Ziekenhuis

    Bonheiden, 2820

  • Institut Jules Bordet

    Brussels, Brussels Capital, 1000

  • Hopital Erasme

    Brussels, Region de Bruxelles-capital, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Grand Hôpital de Charleroi - Site Notre Dame

    Charleroi, Hainaut, 6000

  • UZ Antwerpen

    Edegem, Antwerpen, 2650

  • INDC Entité Jolimontoise - CH de Jolimont-Lobbes

    Haine-Saint-Paul, Hainaut, 7100

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000

  • C.H. de l'Ardenne - site Libramont

    Libramont-Chevigny, Luxembourg, 6800

  • CHU UCL Namur - Site Sainte-Elisabeth

    Namur, 5000

  • Clinique Saint-Pierre

    Ottignies, Brabant Wallon, 1340

  • CHWaPi - Site IMC

    Tournai, Hainaut, 7500

  • GZA Ziekenhuizen - Campus St Augustinus

    Wilrijk, 2610

Other trials in Belgium

Russia12 sites

  • OGBUZ Belgorod Oncology Dispensary

    Belgorod, Belgorod Oblast, 308010

  • GBUZ Chelyabinsk regional clinical center of oncology and nuclear medicine

    Chelyabinsk, 454087

  • FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"

    Lermontov, Stavropol Territory, 357340

  • FSBSI Russian Cancer Research Center n.a.NN Blokhin

    Moscow, 115478

  • GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"

    Pyatigorsk, Stavropol Territory, 357502

  • Saint Petersburg GBUZ "City Clinical Oncology Dispensary"

    Saint Petersburg, 197022

  • Saint Petersburg GBUZ City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • OGBUZ Belgorod Oncology Dispensary

    Stariy Oskol, Belgorod Oblast, 309504

  • GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"

    Stavropol, 355047

  • GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan

    Ufa, Bashkortostan Republic, 450054

  • GBUZ Leningrad regional oncological dispensary

    Village Kuzmolovsky, Leningradskaya Oblast', 188663

  • FGBU Russian Research Center for Radiology and Surgical Technologies

    Village Pesochny, 197758

Other trials in Russia

Canada11 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Cancer Centre of Southeastern Ontario @ Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre, General Campus

    Ottawa, Ontario, K1H 8L6

  • Niagara Health System Walker Family Cancer Center

    St. Catharines, Ontario, L2S 0A9

  • British Columbia Cancer Agency - Fraser Valley Centre

    Surrey, British Columbia, V3V 1Z2

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Japan8 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama,japan, 362-0806

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • National Hospital Organization

    Osaka, 540-0006

Other trials in Japan

Netherlands6 sites

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333ZA

  • Academisch Ziekenhuis Maastricht

    Maastricht, Limburg, 6229 HX

  • Ikazia Ziekenhuis

    Rotterdam, South Holland, 3083 AN

  • Orbis Medisch Centrum

    Sittard-Geleen, Limburg, 6162 BG

  • Haga Ziekenhuis

    The Hague, South Holland, 2545 AA

  • TweeSteden Ziekenhuis

    Tilburg, North Brabant, 5042AD

Other trials in Netherlands

Ukraine6 sites

  • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr"

    Chernivtsi, 58013

  • Komunalnyi zaklad 'Miska klinichna likarnia No.4' Dniprovskoi miskoi rady,

    Dnipro, 49102

  • Komunalne nekomertsiyne pidpryiemstvo "Oblasnyi

    Kharkiv, 61070

  • KNP Lvivskoi oblasnoi rady Lvivskyi onkolohichnyi

    Lviv, 79031

  • Komunalna ustanova "Odeska oblasna klinichna likarnia"

    Odesa, 65025

  • Podilskyi rehionalnyi tsentr onkolohii,

    Vinnytsia, 21029

Other trials in Ukraine

United Kingdom6 sites

  • Velindre Cancer Centre

    Cardiff, South Glamorgan, CF14 2TL

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre

    Portsmouth, Hampshire, PO6 3LY

  • Royal Hallamshire Hospital

    Sheffield, South Yorkshire, S10 2JF

  • Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital

    Sheffield, South Yorkshire, S10 2SJ

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

South Korea5 sites

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 463-707

  • Seoul National University Hospital

    Seoul, 03080

  • Asan medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Germany4 sites

  • Universitaetsklinikum Leipzig AoeR

    Leipzig, 04103

  • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz

    Leipzig, 04103

  • Klinikum der Universität München

    München, 80336

  • Klinikum der Universität München

    München, 80337

Other trials in Germany

Romania4 sites

  • Spitalul Clinic CF nr.2 Bucuresti

    Bucharest, 011464

  • Spitalul Municipal Ploiesti

    Ploieşti, 100337

  • Spitalul Judetean de Urgente "Sf. Ioan cel Nou"

    Suceava, 720237

  • Spitalul Clinic Judetean Mures

    Tg. Mures, 540142

Other trials in Romania

Portugal2 sites

  • Champalimaud Cancer Center/ Breast Unit

    Lisbon, 1400-038

  • Instituto Português de Oncologia

    Porto, 4200-072

Other trials in Portugal

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Ireland1 site

  • Bon Secours Hospital

    Cork

Other trials in Ireland

Turkey (Türkiye)1 site

  • Ege University Medical Faculty

    Izmir, Bornova, 35040

Other trials in Turkey (Türkiye)

About this study

Official title: MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY

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).

Being tested
Palbociclib, Fulvestrant, Placebo
Keywords
Palbociclib (PD-0332991), Fulvestrant, Goserelin, Hormone receptor-+, HER2-negative, Prior Endocrine treatment, any menopausal status, PALOMA-3
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.

  • FulvestrantDrug

    Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.

  • PlaceboDrug

    Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.

  • FulvestrantDrug

    Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.

Study groups in NCT01942135
Study groupRoleWhat they receive
Arm AExperimentalGiven until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Receives: Drug: Palbociclib; Drug: Fulvestrant
Arm BActive comparatorGiven until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Receives: Drug: Placebo; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) as Assessed by the Investigator

    PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.

    Measured: From randomization date to date of first documentation of progression or death (assessed up to 12 months)

Secondary outcomes (19)

  1. Overall Survival (OS)-Number of Participants Who Died

    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.

    Measured: From randomization until death (up to 4.5 years)

  2. Overall Survival (OS)

    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.

    Measured: From randomization until death (up to 4.5 years)

  3. Survival Probabilities at Year 1, Year 2, and Year 3

    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.

    Measured: From randomization until death (assessed up to 36 months)

  4. Objective Response (OR)

    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.

    Measured: From randomization until end of treatment (assessed up to 2 years)

  5. Duration of Response (DR)

    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.

    Measured: From randomization until end of treatment (assessed up to 2 years)

  6. Clinical Benefit Response (CBR)

    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.

    Measured: From randomization until end of treatment (assessed up to 2 years)

  7. Observed Plasma Trough Concentration (Ctrough) for Palbociclib

    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.

    Measured: Cycle 1/Day 15 and Cycle 2/Day 15

  8. Ctrough for Fulvestrant

    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.

    Measured: Cycles 2/Day 1 and Cycle 3/Day 1

  9. Ctrough for Goserelin

    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.

    Measured: Cycles 2/ Day 1 and Cycle 3/ Day 1

  10. 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

    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.

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  11. Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores

    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.

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  12. Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores

    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.

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  13. Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores

    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.

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  14. Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores

    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).

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  15. Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale

    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).

    Measured: From Cycle 1 to 14, as of 05 December 2014.

  16. Time to Deterioration (TTD)

    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.

    Measured: 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

  17. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)

    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.

    Measured: From the date of randomization up to 28 calendar days (±7 days) after last dose of study intervention (up to 8.4 years).

  18. Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Hematology Results

    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.

    Measured: From baseline to end of treatment/withdrawal (up to 4.5 years)

  19. Participants With Shifts From CTCAE Grade ≤2 at Baseline to CTCAE Grade 3 or 4 Postbaseline for Chemistry Results

    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.

    Measured: From baseline to end of treatment/withdrawal (up to 4.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study start26 Sep 2013
  3. Primary completion5 Dec 2014
  4. Study completion28 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
521 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942135
Sponsor's protocol ID
A5481023
Other IDs
2013-002580-26
Status last verified
Apr 2024
First submitted
10 Sep 2013
Last updated
4 Apr 2024
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Li H, Wu Y, Zou H, Koner S, Plichta JK, Tolaney SM, Zhang J, He YW, Wei Q, Tang L, Zhang H, Zhang B, Guo Y, Chen X, Li K, Lian L, Ma F, Luo S. Clinical efficacy of CDK4/6 inhibitor plus endocrine therapy in HR-positive/HER2-0 and HER2-low-positive metastatic breast cancer: a secondary analysis of PALOMA-2 and PALOMA-3 trials. EBioMedicine. 2024 Jul;105:105186. doi: 10.1016/j.ebiom.2024.105186. Epub 2024 Jun 10.

    PubMed 38861871

  • Rugo HS, Im SA, Joy AA, Shparyk Y, Walshe JM, Sleckman B, Loi S, Theall KP, Kim S, Huang X, Bananis E, Mahtani R, Finn RS, Dieras V. Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. Breast. 2022 Dec;66:324-331. doi: 10.1016/j.breast.2022.11.005. Epub 2022 Nov 15.

    PubMed 36463643

  • Zhu Z, Turner NC, Loi S, Andre F, Martin M, Dieras V, Gelmon KA, Harbeck N, Zhang C, Cao JQ, Yan Z, Lu DR, Wei P, VanArsdale TL, Rejto PA, Huang X, Rugo HS, Loibl S, Cristofanilli M, Finn RS, Liu Y. Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib. NPJ Precis Oncol. 2022 Aug 16;6(1):56. doi: 10.1038/s41698-022-00297-1.

    PubMed 35974168

  • Rugo HS, Cristofanilli M, Loibl S, Harbeck N, DeMichele A, Iwata H, Park YH, Brufsky A, Theall KP, Huang X, McRoy L, Bananis E, Turner NC. Prognostic Factors for Overall Survival in Patients with Hormone Receptor-Positive Advanced Breast Cancer: Analyses From PALOMA-3. Oncologist. 2021 Aug;26(8):e1339-e1346. doi: 10.1002/onco.13833. Epub 2021 Jun 12.

    PubMed 34037282

  • Iwata H, Umeyama Y, Liu Y, Zhang Z, Schnell P, Mori Y, Fletcher O, Marshall JC, Johnson JG, Wood LS, Toi M, Finn RS, Turner NC, Bartlett CH, Cristofanilli M. Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3. Oncologist. 2021 Jul;26(7):e1143-e1155. doi: 10.1002/onco.13811. Epub 2021 Jun 7.

    PubMed 33955129

  • Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Dieras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.

    PubMed 33486783

  • Finn RS, Cristofanilli M, Ettl J, Gelmon KA, Colleoni M, Giorgetti C, Gauthier E, Liu Y, Lu DR, Zhang Z, Bartlett CH, Slamon DJ, Turner NC, Rugo HS. Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials. Breast Cancer Res Treat. 2020 Nov;184(1):23-35. doi: 10.1007/s10549-020-05782-4. Epub 2020 Aug 11.

    PubMed 32783178

  • Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.

    PubMed 32164785

  • Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M. Neutropenia management with palbociclib in Japanese patients with advanced breast cancer. Breast Cancer. 2019 Sep;26(5):637-650. doi: 10.1007/s12282-019-00970-7. Epub 2019 May 24.

    PubMed 31127500

  • Turner NC, Liu Y, Zhu Z, Loi S, Colleoni M, Loibl S, DeMichele A, Harbeck N, Andre F, Bayar MA, Michiels S, Zhang Z, Giorgetti C, Arnedos M, Huang Bartlett C, Cristofanilli M. Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer. J Clin Oncol. 2019 May 10;37(14):1169-1178. doi: 10.1200/JCO.18.00925. Epub 2019 Feb 26.

    PubMed 30807234

  • Masuda N, Inoue K, Nakamura R, Rai Y, Mukai H, Ohno S, Hara F, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Huang X, Iwata H. Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients. Int J Clin Oncol. 2019 Mar;24(3):262-273. doi: 10.1007/s10147-018-1359-3. Epub 2018 Nov 3.

    PubMed 30392115

  • Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Andre F, Puyana Theall K, Huang X, Giorgetti C, Huang Bartlett C, Cristofanilli M. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018 Nov 15;379(20):1926-1936. doi: 10.1056/NEJMoa1810527. Epub 2018 Oct 20.

    PubMed 30345905

  • Cristofanilli M, DeMichele A, Giorgetti C, Turner NC, Slamon DJ, Im SA, Masuda N, Verma S, Loi S, Colleoni M, Theall KP, Huang X, Liu Y, Bartlett CH. Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3. Eur J Cancer. 2018 Nov;104:21-31. doi: 10.1016/j.ejca.2018.08.011. Epub 2018 Oct 8.

    PubMed 30308388

  • Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.

    PubMed 30053671

  • Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

    PubMed 30032196

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palbociclib and Fulvestrant in people with Metastatic Breast Cancer, run by Pfizer at 247 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in United States, Italy, Australia, Belgium, Russia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942135, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.

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