AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT01740427

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

A Phase 3 study testing PD-0332991 and Letrozole in people with Breast Neoplasms, run by Pfizer at 305 sites in 18 countries.

Completed

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

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
PD-0332991 and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
666 participants
Where
305 sitesin 18 countries
Study dates
22 Feb 2013to 9 Nov 2023
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

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

Who cannot join

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

Trial locations and contacts

305 sites in 18 countries.

305 sites in 18 countries

United States136 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Mercy Clinic St. Louis Cancer and Breast Institute

    Ballwin, Missouri, 63011

  • University of Maryland, Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Southern California Permanente Medical Group

    Bellflower, California, 90706

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

    Blacksburg, Virginia, 24060

  • CareMount Medical

    Brewster, New York, 10509

  • The Mark M. Connolly Center for Cancer and Specialty Care

    Chicago, Illinois, 60657

  • Kootenai Clinic Cancer Services

    Coeur d'Alene, Idaho, 83814

  • The West Clinic, PC

    Corinth, Mississippi, 38834

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Carle Foundation Hospital DBA Carle Cancer Center

    Danville, Illinois, 61832

  • Sylvester at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Carle Foundation Hospital DBA Carle Cancer Center

    Effingham, Illinois, 62401

  • Texas oncology-west Texas

    El Paso, Texas, 79902

  • Texas oncology-West Texas

    El Paso, Texas, 79915

  • Texas Oncology-west Texas

    El Paso, Texas, 79938

  • Presence Infusion Care- Evanston

    Evanston, Illinois, 60202

  • Investigational Products Center (IPC)

    Fort Worth, Texas, 76177

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • The West Clinic, PC dba West Cancer Centre

    Germantown, Tennessee, 38138

  • Los Angeles Hematology/Oncology Medical Group

    Glendale, California, 91206

  • Saint Francis Medical Center

    Grand Island, Nebraska, 68802

  • Saint Francis Medical Center, Saint Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • St. Mary's Hospital Regional Cancer Center

    Grand Junction, Colorado, 81501

  • Saint Francis Medical Center

    Hastings, Nebraska, 68901

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074-8195

  • Tennessee Oncology PLLC

    Hermitage, Tennessee, 37076

  • 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

  • The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center.

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA Hematology/ Oncology- Irvine

    Irvine, California, 92604

  • US Oncology Investigational Products Center

    Irving, Texas, 75063

  • Cancer Specialist of North Florida, Pharmacy

    Jacksonville, Florida, 32256

  • Cancer Specialists of North Florida-Southpoint

    Jacksonville, Florida, 32256

  • UCLA Hematology Oncology- Laguna Hills

    Laguna Hills, California, 92653

  • Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department

    Las Vegas, Nevada, 89119

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37090

  • Los Angeles Hematology/Oncology Medical Group

    Los Angeles, California, 90017

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Translational Research Management

    Los Angeles, California, 90045

  • Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

    Los Angeles, California, 90095-1772

  • UCLA West Medical Pharmacy, Attn: Steven L. Wong

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy: Drug Management Only

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy; Drug Management Only

    Los Angeles, California, 90095-7349

  • UCLA West Medical Pharmacy

    Los Angeles, California, 90095-7349

  • Administrative Address: UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.

    Los Angeles, California, 90095

  • Regulatory Management Only: TRIO-US Central Administration

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • TRIO-US Central Administration: Regulatory Management Only

    Los Angeles, California, 90095

  • TRIO-US Central Administration

    Los Angeles, California, 90095

  • UCLA Hematology Oncology

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • James Graham Brown Cancer Center and University Hospital

    Louisville, Kentucky, 40202

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Low Moor, Virginia, 24457

  • University of Wisconsin

    Madison, Wisconsin, 53792-6164

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Carle Foundation Hospital DBA Carle Cancer Center

    Mattoon, Illinois, 61938

  • The West Clinic, PC dba West Cancer Centre

    Memphis, Tennessee, 38104

  • WVU Medicine

    Morgantown, West Virginia, 26506

  • CareMount Medical

    Mount Kisco, New York, 10549

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37211

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia oncology Associates

    Norfolk, Virginia, 23502

  • Whittingham Cancer Center @ Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Orlando Health, Inc.

    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

  • Sylvester Comprehensive Cancer Center Plantation

    Plantation, Florida, 33324

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • Kaiser Permanente Northwest Region

    Portland, Oregon, 97227

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • OHSU Center for Health and Healing 2

    Portland, Oregon, 97239

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239

  • OHSU Research Pharmacy Services

    Portland, Oregon, 97239

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Kootenai Clinic Cancer Services

    Post Falls, Idaho, 83854

  • Torrance Health Association, DBa Torrance Memorial Physician Network

    Redondo Beach, California, 90277

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Cancer Specialists of North Florida - St. Augustine

    Saint Augustine, Florida, 32086

  • Park Nicollet Frauenshuh Cancer Center

    Saint Louis Park, Minnesota, 55426

  • Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • Southern California Permanente Medical Group

    San Diego, California, 92108

  • University of California, San Francisco

    San Francisco, California, 94115

  • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

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

    San Luis Obispo, California, 93401

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Santa Monica Medical Center and Orthopaedic Hospital

    Santa Monica, California, 90404

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Presence Infusion Care- Skokie

    Skokie, Illinois, 60077

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167

  • The West Clinic, PC dba West Cancer Centre

    Southaven, Mississippi, 38671

  • Mercy Clinic St. Louis Cancer and Breast Institute

    St Louis, Missouri, 63109

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

    St Louis, Missouri, 63141

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Stanford Women's Cancer Center

    Stanford, California, 94304-5826

  • Stony Brook University- Cancer Center

    Stony Brook, New York, 11794-9447

  • Carle Foundation Hospital DBA Carle Cancer Center

    Urbana, Illinois, 61801

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98683

  • Northwest Cancer Specialists P.C.

    Vancouver, Washington, 98684

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Wellness Oncology & Hematology

    West Hills, California, 91307

  • UCLA Hematology/Oncology- Westlake

    Westlake Village, California, 91361

  • Shenandoah Oncology PC

    Winchester, Virginia, 22601

  • Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

Spain22 sites

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Hospital Universitario Fundacion de Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitario Infanta Cristina

    Badajoz, 06080

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital de Donostia

    Donostia / San Sebastian, 20014

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Instituto Catalan de Oncologia L'Hospitalet

    L'Hospitalet de Llobregat (Barcelona), 08908

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Centro Oncologico MD Anderson Internacional España

    Madrid, 28033

  • Hospital Clinico San Carlos

    Madrid, 28040

  • HOSPITAL Universitario 12 DE OCTUBRE

    Madrid, 28041

  • Hospital Madrid Universitario Sanchinarro

    Madrid, 28050

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

Australia16 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Icon Cancer Care

    Auchenflower, Queensland, 4066

  • Bendigo Health Care Group, The Bendigo Hospital Campus

    Bendigo, Victoria, 3550

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Northern Hospital

    Epping, Victoria, 3076

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Laverty Pathology

    Port Macquarie, New South Wales, 2444

  • Mid North Coast Diagnostic Imaging

    Port Macquarie, New South Wales, 2444

  • Epworth Healthcare

    Richmond, Victoria, 3121

  • Maroondah Hospital

    Ringwood East, Victoria, 3135

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • Icon Cancer Care Corporate Office

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Japan15 sites

  • Chiba Cancer Center

    Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518

  • Hakuaikai Medical Corporation Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • Saitama Cancer Center

    Kita-adachi-gun, Saitama, 362-0806

  • Kumamoto City Hospital

    Kumamoto, Kumamoto, 862-8505

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Niigata Cancer Center Hospital 2-15-3

    Niigata, 951-8566

  • Iwate Medical University Hospital

    Numakunai, 020-8505

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

Other trials in Japan

Canada14 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre, Victoria General Site

    Halifax, Nova Scotia, B3H 2Y9

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

    Montreal, Quebec, H4A 3J1

  • Hopital du Sacre-Coeur

    Montreal, Quebec, H4J 1C5

  • Southlake Regional Health Centre- Stronach Regional Cancer Centre

    Newmarket, Ontario, L3Y2P9

  • Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BC Cancer Agency-Fraser Valley Centre

    Surrey, British Columbia, V3V 1Z2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • St. Michaels Hospital

    Toronto, Ontario, M5B 1W8

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency-Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Russia13 sites

  • GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan

    Kazan', 420029

  • Regional Budgetary Healthcare Institution Kursk Regional Clinical

    Kursk, Kursk Oblast, 305524

  • State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"

    Kuzmolovo, Leningradskaya Oblast', 188663

  • Federal State Budget Institution

    Moscow, 115478

  • State Budget Healthcare Institution Moscow City Oncology Hospital

    Moscow Area, 143423

  • Budget Institution of Healthcare

    Omsk, 644013

  • Budget Institution of Healthcare

    Omsk, 644046

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan, 390011

  • Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways

    Saint Petersburg, 195271

  • Saint-Petersburg State Budget Healthcare Institution (SBHCI)

    Saint Petersburg, 198255

  • Republican Clinical Hospital n.a. G.G. Kuvatov

    Ufa, 450005

  • State Budget Medical Institution Republican Clinical Oncology

    Ufa, 450054

  • SBHI of Republic of Bashkortostan Emergency Hospital

    Ufa, 450106

Other trials in Russia

France12 sites

  • Institut de Cancerologie de l'Ouest- Paul Papin

    Anger Cedex 02, 49055

  • Centre François Baclesse

    Caen, 14076

  • Centre Georges François Leclerc

    Dijon, 21079

  • CHD Vendée

    La Roche-sur-Yon, 85295

  • Centre Val d'Aurelle,

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut Curie, Departement d'Oncologie Medicale

    Paris, 75248

  • Centre Eugene Marquis

    Rennes, 35042

  • Hopital Rene Huguenin/Institut Curie

    Saint-Cloud, 92210

  • Institut de Cancérologie de l'Ouest-Rene Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department

    Toulouse Cedex-9, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany12 sites

  • Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen

    Böblingen, 71032

  • University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.

    Dresden, 01307

  • Universitatsklinikum Erlangen, Frauenklinik

    Erlangen, 91054

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe

    Kiel, 24105

  • Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik

    Magdeburg, 39108

  • Katholisches Klinikum Mainz

    Mainz, 55131

  • Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

    München, 81675

  • IOZ- Munchen, PGM- Studien GmbH

    Munich, Bavaria, 80336

  • Rotkreuzklinikum Munchen, Frauenklinik,

    Munich, 80637

  • Breast Cancer, University of Munich, Grosshadern Hospital

    Munich, 81377

  • Klinikum Mutterhaus

    Trier, 54290

Other trials in Germany

Hungary11 sites

  • Szent Margit Korhaz

    Budapest, 1032

  • Affidea Diagnosztika Kft.

    Budapest, 1054

  • Orszagos Onkologiai Intezet ,

    Budapest, 1122

  • Országos Onkológiai Intézet "B" Belgyogyaszati osztaly

    Budapest, H-1122

  • Országos Onkológiai Intézet, Nuklearis Medicina Osztaly

    Budapest, H-1122

  • Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily

    Budapest, H-1122

  • Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly

    Győr, 9024

  • Josa Andras Teaching Hospital,

    Nyíregyháza, 4400

  • Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet

    Szeged, 6720

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar

    Szeged, 6720

  • Diagnoscan Magyarorszag Kft.

    Szeged, 6725

Other trials in Hungary

Ukraine10 sites

  • MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council

    Dnipro, 49102

  • State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine

    Dnipro, 49102

  • Municipal Non-profit Enterprise "Regional Centre of Oncology"

    Kharkiv, 61070

  • Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department

    Lviv, 79031

  • Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"

    Makiivka, 86120

  • Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

    Sumy, 40005

  • City Oncology Centre of Central Municipal Clinical Hospital

    Uzhhorod, 88000

  • Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.

    Uzhhorod, 88000

  • MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,

    Zaporizhzhya, 69040

  • State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",

    Zaporizhzhya, 69040

Other trials in Ukraine

Belgium8 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Brussel

    Brussels, 1090

  • Oncologie

    Brussels, 1200

  • Grand Hopital de Charleroi / Service d'Hematologie et Oncologie

    Charleroi, 6000

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, 3000

  • CHU Start Tilman

    Liège, 4000

  • CHR East Belgium - Verviers

    Verviers, 4800

  • Gasthuis Zusters Antwerpen - Campus Sint- Augustinus

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Ireland8 sites

  • Bon Secours Hospital

    Cork

  • St. James Hospital

    Dublin, 8

  • Beaumont Hospital

    Dublin, 9

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7

  • St Vincents University Hospital

    Dublin

  • Department of Medical Oncology

    Galway

  • Mid Western Regional Hospital

    Limerick

  • Waterford Regional Hospital

    Waterford

Other trials in Ireland

United Kingdom8 sites

  • Edinburgh Cancer Centre, Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Beatson Institute for Cancer Research

    Glasgow, Scotland, G12 0YN

  • Guys Hospital

    London, SE1 9RT

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Charing Cross Hospital

    London, W6 8RF

  • Kent Oncology Center

    Maidstone, KENT, ME16 9QQ

  • Christie Hospital NHS Foundation Trust

    Manchester, M20 4BX

  • The Research And Development Office, The Christie NHS Foundation Trust

    Manchester, M204BX

Other trials in United Kingdom

Italy7 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100

  • Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

    Bologna, BO, 40138

  • Irccs Irst

    Meldola, FC, 47014

  • IRCCS - Istituto Europeo di Oncologia

    Milan, Milan, 20141

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

  • Istituti Fisioterapici Ospitalieri

    Roma, 00128

  • Ospedale SS Trinita

    Sora (FR), 03039

Other trials in Italy

South Korea6 sites

  • National Cancer Center, Center for Breast Cancer

    Goyang-si, Gyeonggi-do, 10408

  • Severance Hospital, Yonsei University Health System

    Seodaemun-gu, Seoul, 03722

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital / Department of Internal Medicine

    Seoul, 03080

  • Asan Medical Center, Division of Oncology, Department of Internal Medicine

    Seoul, 05505

  • Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

    Seoul, 06351

Other trials in South Korea

Poland3 sites

  • Oncology and Radiotherapy Clinic

    Gdansk, 80-214

  • Europejskie Centrum Zdrowia Otwock

    Otwock, Masovian Voivodeship, 05-400

  • Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian

    Żory, 44-240

Other trials in Poland

Taiwan3 sites

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memory Hospital

    Taipei, 10449

  • Veterans General Hospital-Taipei

    Taipei, 11217

Other trials in Taiwan

Czechia1 site

  • Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie

    Hradec Králové, 500 05

Other trials in Czechia

About this study

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

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

Being tested
PD-0332991, Letrozole, Placebo
Keywords
breast cancer, postmenopausal women, estrogen-receptor positive, HER2 negative, locoregionally recurrent, metastatic, Palbociclib (PD-0332991), PALOMA-2
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

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

  • PD-0332991Drug

    PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

  • LetrozoleDrug

    Letrozole, 2.5mg, orally once daily (continuously)

  • PlaceboDrug

    Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

  • LetrozoleDrug

    Letrozole, 2.5mg, orally once daily (continuously)

Study groups in NCT01740427
Study groupRoleWhat they receive
PD-0332991 + LetrozoleExperimentalPD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Receives: Drug: PD-0332991; Drug: Letrozole
Placebo + LetrozoleActive comparatorPlacebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Receives: Drug: Placebo; Drug: Letrozole

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

    Measured: From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)

Secondary outcomes (15)

  1. Objective Response as Assessed by the Investigator

    Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

    Measured: From randomization until end of treatment (up to approximately 2.5 years)

  2. Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator

    The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

    Measured: From randomization until end of treatment (up to approximately 2.5 years)

  3. 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 will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

    Measured: From randomization until end of treatment (up to approximately 2.5 years)

  4. Disease Control (DC)/Clinical Benefit Response (CBR)

    DC is defined as overall CR, PR, or stable disease (SD) >=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD >=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.

    Measured: From randomization until end of treatment (up to approximately 2.5 years)

  5. PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)

    PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score >=1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.

    Measured: From randomization until end of treatment (up to approximately 24 Months)

  6. Corrected QT Interval (QTc) Time-Matched Change From Baseline on Cycle 1 Day 14

    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.

    Measured: Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14

  7. Percentage of Participants With Corrected QT Interval (QTc)

    Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.

    Measured: For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10 (ECGs beyond Cycle 10 were performed as clinically indicated)

  8. Observed Plasma Trough Concentration (Ctrough) at Steady-State

    Summary of plasma palbociclib within-participant mean steady-state trough concentrations.

    Measured: 0 hour (predose) on Day 14 of cycles 1 and 2

  9. Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

    The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).

    Measured: From Baseline up to 2.5 years

  10. Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)

    FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.

    Measured: From Baseline up to 2.5 years

  11. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs): All Causalities

    An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE. Discontinuation included permanent, temporary discontinuation and dose reduction due to AEs.

    Measured: From date of randomization up to 28 days after last dose of study drug (final analysis till study completion, approximately up to 10.51 years)

  12. Overall Survival (OS): Primary Analysis

    OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at primary analysis.

    Measured: From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)

  13. Overall Survival (OS): Final Analysis

    OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive. Data for this outcome measure was reported at final analysis.

    Measured: From date of randomization until death due to any cause or censored (final analysis till study completion, approximately up to 10.51 years)

  14. Survival Probability at 1 Year, 2 Year and 3 Year

    One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.

    Measured: 1, 2 and 3 years after randomization

  15. Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade

    Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.

    Measured: From randomization up to 28 days after last dose of study drug (assessed up to analysis date of 15-Nov-2021, approximately 8.7 years)

Timeline

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

  1. First posted4 Dec 2012 (estimated)
  2. Study start22 Feb 2013
  3. Primary completion26 Feb 2016
  4. Study completion9 Nov 2023

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01740427
Sponsor's protocol ID
A5481008
Other IDs
2012-004601-27, PALMOA-2, PALOMA-2
Status last verified
Oct 2024
First submitted
26 Nov 2012
Last updated
14 Nov 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

  • Cheang MCU, Rimawi M, Johnston S, Jacobs SA, Bliss J, Pogue-Geile K, Kilburn L, Zhu Z, Schuster EF, Xiao H, Swaim L, Deng S, Lu DR, Gauthier E, Tursi J, Slamon DJ, Rugo HS, Finn RS, Liu Y. Effect of cross-platform gene-expression, computational methods on breast cancer subtyping in PALOMA-2 and PALLET studies. NPJ Breast Cancer. 2024 Jun 29;10(1):54. doi: 10.1038/s41523-024-00658-y.

    PubMed 38951507

  • 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

  • Slamon DJ, Dieras V, Rugo HS, Harbeck N, Im SA, Gelmon KA, Lipatov ON, Walshe JM, Martin M, Chavez-MacGregor M, Bananis E, Gauthier E, Lu DR, Kim S, Finn RS. Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer. J Clin Oncol. 2024 Mar 20;42(9):994-1000. doi: 10.1200/JCO.23.00137. Epub 2024 Jan 22.

    PubMed 38252901

  • Jhaveri K, O'Shaughnessy J, Fasching PA, Tolaney SM, Yardley DA, Sharma VK, Biswas C, Thuerigen A, Pathak P, Rugo HS. Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer. Ther Adv Med Oncol. 2023 Dec 14;15:17588359231216095. doi: 10.1177/17588359231216095. eCollection 2023.

    PubMed 38107828

  • 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

  • Gelmon K, Walshe JM, Mahtani R, Joy AA, Karuturi M, Neven P, Lu DR, Kim S, Schnell P, Bananis E, Schwartzberg L. Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2. Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.

    PubMed 34388698

  • 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

  • Zheng J, Yu Y, Durairaj C, Dieras V, Finn RS, Wang DD. Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. Target Oncol. 2021 Jan;16(1):69-76. doi: 10.1007/s11523-020-00771-5.

    PubMed 33211314

  • 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

  • Huang Bartlett C, Mardekian J, Cotter MJ, Huang X, Zhang Z, Parrinello CM, Bourla AB. Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer. PLoS One. 2020 Apr 21;15(4):e0227256. doi: 10.1371/journal.pone.0227256. eCollection 2020.

    PubMed 32315295

  • 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

  • Rugo HS, Finn RS, Gelmon K, Joy AA, Harbeck N, Castrellon A, Mukai H, Walshe JM, Mori A, Gauthier E, Lu DR, Bananis E, Martin M, Dieras V. Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2. Clin Breast Cancer. 2020 Apr;20(2):e173-e180. doi: 10.1016/j.clbc.2019.08.009. Epub 2019 Sep 5.

    PubMed 31836434

  • Dieras V, Harbeck N, Joy AA, Gelmon K, Ettl J, Verma S, Lu DR, Gauthier E, Schnell P, Mori A, Rugo HS, Finn RS. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Oncologist. 2019 Dec;24(12):1514-1525. doi: 10.1634/theoncologist.2019-0019. Epub 2019 Jun 19.

    PubMed 31217344

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PD-0332991 and Letrozole in people with Breast Neoplasms, run by Pfizer at 305 sites in 18 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 8 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 305 sites in United States, Spain, Australia, Japan, Canada and 13 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 26 Apr 2017). 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 (up to approximately 2.5 years)). 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 NCT01740427, which also lists 25 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 14 Nov 2024.

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