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

PHASE3CompletedINTERVENTIONAL
Enrollment

666

Participants

Timeline

Start Date

February 22, 2013

Primary Completion Date

February 26, 2016

Study Completion Date

November 9, 2023

Conditions
Breast Neoplasms
Interventions
DRUG

PD-0332991

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

DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

DRUG

Placebo

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

DRUG

Letrozole

Letrozole, 2.5mg, orally once daily (continuously)

Trial Locations (305)

8

St. James Hospital, Dublin

9

Beaumont Hospital, Dublin

1000

Institut Jules Bordet, Brussels

1032

Szent Margit Korhaz, Budapest

1054

Affidea Diagnosztika Kft., Budapest

1090

UZ Brussel, Brussels

1122

Orszagos Onkologiai Intezet ,, Budapest

1200

Oncologie, Brussels

2010

St Vincent's Hospital Sydney, Darlinghurst

2298

Calvary Mater Newcastle, Waratah

2444

Laverty Pathology, Port Macquarie

Mid North Coast Diagnostic Imaging, Port Macquarie

2610

Gasthuis Zusters Antwerpen - Campus Sint- Augustinus, Wilrijk

3000

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

3050

Royal Melbourne Hospital, Parkville

3076

Northern Hospital, Epping

3121

Epworth Healthcare, Richmond

3135

Maroondah Hospital, Ringwood East

3550

Bendigo Health Care Group, The Bendigo Hospital Campus, Bendigo

3630

Goulburn Valley Health, Shepparton

4000

CHU Start Tilman, Liège

4066

Icon Cancer Care, Auchenflower

4101

Icon Cancer Care Corporate Office, South Brisbane

4102

Princess Alexandra Hospital, Woolloongabba

4400

Josa Andras Teaching Hospital,, Nyíregyháza

4575

Sunshine Coast University Hospital, Birtinya

4800

CHR East Belgium - Verviers, Verviers

5000

Royal Adelaide Hospital, Adelaide

6000

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

6150

Fiona Stanley Hospital, Murdoch

6720

Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet, Szeged

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

6725

Diagnoscan Magyarorszag Kft., Szeged

9024

Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly, Győr

10002

National Taiwan University Hospital, Taipei

10032

Columbia University Medical Center, New York

10408

National Cancer Center, Center for Breast Cancer, Goyang-si

10449

Mackay Memory Hospital, Taipei

10509

CareMount Medical, Brewster

10549

CareMount Medical, Mount Kisco

Northern Westchester Hospital, Mount Kisco

11217

Veterans General Hospital-Taipei, Taipei

13620

Seoul National University Bundang Hospital, Seongnam-si

14076

Centre François Baclesse, Caen

15009

Centro Oncologico de Galicia, A Coruña

20007

MedStar Georgetown University Hospital, Washington D.C.

20014

Hospital de Donostia, Donostia / San Sebastian

20141

IRCCS - Istituto Europeo di Oncologia, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21079

Centre Georges François Leclerc, Dijon

21201

University of Maryland, Greenebaum Cancer Center, Baltimore

22601

Shenandoah Oncology PC, Winchester

23007

Complejo Hospitalario de Jaen, Jaén

23456

Virginia Oncology Associates, Virginia Beach

23502

Virginia oncology Associates, Norfolk

23606

Virginia Oncology Associates, Newport News

24014

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

24060

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

24105

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

24153

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

24382

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

24457

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

25198

Hospital Universitario Arnau de Vilanova de Lleida, Lleida

26506

WVU Medicine, Morgantown

28007

Hospital General Universitario Gregorio Marañon, Madrid

28033

Centro Oncologico MD Anderson Internacional España, Madrid

28040

Hospital Clinico San Carlos, Madrid

28041

HOSPITAL Universitario 12 DE OCTUBRE, Madrid

28050

Hospital Madrid Universitario Sanchinarro, Madrid

28922

Hospital Universitario Fundacion de Alcorcon, Alcorcón

30060

Northwest Georgia Oncology Centers, PC, Marietta

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital, Atlanta

The Emory Clinic, Atlanta

Winship Cancer Institute, Atlanta

31059

Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department, Toulouse Cedex-9

32086

Cancer Specialists of North Florida - St. Augustine, Saint Augustine

32256

Cancer Specialist of North Florida, Pharmacy, Jacksonville

Cancer Specialists of North Florida-Southpoint, Jacksonville

32806

Orlando Health, Inc., Orlando

33021

Memorial Breast Cancer Center at Memorial Regional Hospital, Hollywood

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood

Memorial Regional Hospital, Hollywood

33028

Memorial Breast Cancer Center at Memorial Hospital West, Pembroke Pines

Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines

Memorial Hospital West, Pembroke Pines

33324

Sylvester Comprehensive Cancer Center Plantation, Plantation

33442

Sylvester at Deerfield Beach, Deerfield Beach

34298

Centre Val d'Aurelle,, Montpellier

35042

Centre Eugene Marquis, Rennes

37055

Tennessee Oncology, PLLC, Dickson

37066

Tennessee Oncology, PLLC, Gallatin

37067

Tennessee Oncology PLLC, Franklin

37076

Tennessee Oncology PLLC, Hermitage

37090

Tennessee Oncology, PLLC, Lebanon

37129

Tennessee Oncology PLLC, Murfreesboro

37160

Tennessee Oncology, PLLC, Shelbyville

37167

Tennessee Oncology PLLC, Smyrna

37203

Sarah Cannon Research Institute, Nashville

Tennessee Oncology, PLLC, Nashville

37205

Tennessee Oncology PLLC, Nashville

37207

Tennessee Oncology PLLC, Nashville

37211

Tennessee Oncology PLLC, Nashville

38104

The West Clinic, PC dba West Cancer Centre, Memphis

38138

The West Clinic, PC dba West Cancer Centre, Germantown

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

38671

The West Clinic, PC dba West Cancer Centre, Southaven

38834

The West Clinic, PC, Corinth

39108

Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik, Magdeburg

40005

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

40138

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

40202

James Graham Brown Cancer Center and University Hospital, Louisville

James Graham Brown Cancer Center, Louisville

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

44805

Institut de Cancérologie de l'Ouest-Rene Gauducheau, Saint-Herblain

46009

Instituto Valenciano de Oncologia, Valencia

47014

Irccs Irst, Meldola

48109

University of Michigan Health System, Ann Arbor

49055

Institut de Cancerologie de l'Ouest- Paul Papin, Anger Cedex 02

49102

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

State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine, Dnipro

54290

Klinikum Mutterhaus, Trier

55131

Katholisches Klinikum Mainz, Mainz

55426

Park Nicollet Frauenshuh Cancer Center, Saint Louis Park

56126

Azienda Ospedaliero-Universitaria Pisana, Pisa

60077

Presence Infusion Care- Skokie, Skokie

60202

Presence Infusion Care- Evanston, Evanston

60657

The Mark M. Connolly Center for Cancer and Specialty Care, Chicago

61070

"Municipal Non-profit Enterprise Regional Centre of Oncology", Kharkiv

61801

Carle Foundation Hospital DBA Carle Cancer Center, Urbana

61832

Carle Foundation Hospital DBA Carle Cancer Center, Danville

61938

Carle Foundation Hospital DBA Carle Cancer Center, Mattoon

62401

Carle Foundation Hospital DBA Carle Cancer Center, Effingham

63011

Mercy Clinic St. Louis Cancer and Breast Institute, Ballwin

63109

Mercy Clinic St. Louis Cancer and Breast Institute, St Louis

63141

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

Mercy Hospital St. Louis, St Louis

68802

Saint Francis Medical Center, Grand Island

68803

Saint Francis Medical Center, Saint Francis Cancer Treatment Center, Grand Island

68901

Saint Francis Medical Center, Hastings

69040

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

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

71032

Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen, Böblingen

75063

US Oncology Investigational Products Center, Irving

75231

Texas Oncology-Dallas Presbyterian Hospital, Dallas

75246

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

75248

Institut Curie, Departement d'Oncologie Medicale, Paris

76177

Investigational Products Center (IPC), Fort Worth

77030

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

The University of Texas MD Anderson Cancer Center., Houston

The University of Texas MD Anderson Cancer Center, Houston

79031

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

79902

Texas oncology-west Texas, El Paso

79915

Texas oncology-West Texas, El Paso

79938

Texas Oncology-west Texas, El Paso

80336

IOZ- Munchen, PGM- Studien GmbH, Munich

80637

Rotkreuzklinikum Munchen, Frauenklinik,, Munich

81377

Breast Cancer, University of Munich, Grosshadern Hospital, Munich

81501

St. Mary's Hospital Regional Cancer Center, Grand Junction

81675

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

83100

Azienda Ospedaliera San Giuseppe Moscati, Avellino

83814

Kootenai Clinic Cancer Services, Coeur d'Alene

83854

Kootenai Clinic Cancer Services, Post Falls

85295

CHD Vendée, La Roche-sur-Yon

86120

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

88000

City Oncology Centre of Central Municipal Clinical Hospital, Uzhhorod

Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ., Uzhhorod

89052

Comprehensive Cancer Centers of Nevada, Henderson

89119

Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department, Las Vegas

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

89148

Comprehensive Cancer Centers of Nevada, Las Vegas

89169

Comprehensive Cancer Centers of Nevada, Las Vegas

90017

Los Angeles Hematology/Oncology Medical Group, Los Angeles

90027

Southern California Permanente Medical Group, Los Angeles

90045

Translational Research Management, Los Angeles

90095

Administrative Address: UCLA Hematology/Oncology, Los Angeles

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

Regulatory Management Only: TRIO-US Central Administration, Los Angeles

Ronald Reagan UCLA Medical Center, Los Angeles

TRIO-US Central Administration: Regulatory Management Only, Los Angeles

TRIO-US Central Administration, Los Angeles

UCLA Hematology Oncology, Los Angeles

UCLA Hematology/Oncology, Los Angeles

90211

Beverly Hills Cancer Center, Beverly Hills

90277

Torrance Health Association, DBa Torrance Memorial Physician Network, Redondo Beach

90404

UCLA Santa Monica Medical Center and Orthopaedic Hospital, Santa Monica

90706

Southern California Permanente Medical Group, Bellflower

91054

Universitatsklinikum Erlangen, Frauenklinik, Erlangen

91105

UCLA Hematology/ Oncology- Pasadena, Pasadena

91206

Los Angeles Hematology/Oncology Medical Group, Glendale

91307

Wellness Oncology & Hematology, West Hills

91361

UCLA Hematology/Oncology- Westlake, Westlake Village

92108

Southern California Permanente Medical Group, San Diego

92210

Hopital Rene Huguenin/Institut Curie, Saint-Cloud

92604

UCLA Hematology/ Oncology- Irvine, Irvine

92653

UCLA Hematology Oncology- Laguna Hills, Laguna Hills

92835

St. Joseph Heritage Healthcare, Fullerton

93401

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

93454

Central Coast Medical Oncology Corporation, Santa Maria

94115

University of California, San Francisco, San Francisco

94158

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

94805

Institut Gustave Roussy, Villejuif

97213

Northwest Cancer Specialists, PC, Portland

97227

Kaiser Permanente Northwest Region, Portland

Northwest Cancer Specialists, P.C., Portland

97239

OHSU Center for Health and Healing 2, Portland

OHSU Center for Health and Healing, Portland

OHSU Research Pharmacy Services, Portland

Oregon Health and Science University, Portland

98109

Seattle Cancer Care Alliance, Seattle

98683

Northwest Cancer Specialists, P.C., Vancouver

98684

Northwest Cancer Specialists P.C., Vancouver

115478

Federal State Budget Institution, Moscow

143423

State Budget Healthcare Institution Moscow City Oncology Hospital, Moscow Area

188663

"State Budget Healthcate Institution Leningrad Region Oncology Dispensary", Kuzmolovo

195271

"Non-State Health Care agency Road Clinical Hospital of PLC Russian Railways", Saint Petersburg

198255

Saint-Petersburg State Budget Healthcare Institution (SBHCI), Saint Petersburg

305524

Regional Budgetary Healthcare Institution Kursk Regional Clinical, Kursk

390011

Ryazan Regional Clinical Oncology Dispensary, Ryazan

420029

GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan, Kazan'

450005

Republican Clinical Hospital n.a. G.G. Kuvatov, Ufa

450054

State Budget Medical Institution Republican Clinical Oncology, Ufa

450106

SBHI of Republic of Bashkortostan Emergency Hospital, Ufa

644013

Budget Institution of Healthcare, Omsk

644046

Budget Institution of Healthcare, Omsk

90095-1772

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

90095-7349

UCLA West Medical Pharmacy, Attn: Steven L. Wong, Los Angeles

UCLA West Medical Pharmacy: Drug Management Only, Los Angeles

UCLA West Medical Pharmacy; Drug Management Only, Los Angeles

UCLA West Medical Pharmacy, Los Angeles

94304-5826

Stanford Women's Cancer Center, Stanford

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

06856

Whittingham Cancer Center @ Norwalk Hospital, Norwalk

20889-5600

Walter Reed National Military Medical Center, Bethesda

89074-8195

Comprehensive Cancer Centers of Nevada, Henderson

11794-9447

Stony Brook University- Cancer Center, Stony Brook

53792-6164

University of Wisconsin, Madison

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V3V 1Z2

BC Cancer Agency-Fraser Valley Centre, Surrey

V5Z 4E6

British Columbia Cancer Agency-Vancouver Centre, Vancouver

B3H 2Y9

QEII Health Sciences Centre, Victoria General Site, Halifax

N6A 4L6

London Regional Cancer Program, London

L3Y2P9

Southlake Regional Health Centre- Stronach Regional Cancer Centre, Newmarket

M4N 3M5

Sunnybrook Research Institute, Toronto

M5B 1W8

St. Michaels Hospital, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H4A 3J1

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

H4J 1C5

Hopital du Sacre-Coeur, Montreal

G1S 4L8

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

S4T 7T1

Allan Blair Cancer Centre, Regina

500 05

Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie, Hradec Králové

06189

Centre Antoine Lacassagne, Nice

01307

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

H-1122

"Országos Onkológiai Intézet B Belgyogyaszati osztaly", Budapest

Országos Onkológiai Intézet, Nuklearis Medicina Osztaly, Budapest

Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily, Budapest

Unknown

Bon Secours Hospital, Cork

St Vincents University Hospital, Dublin

Department of Medical Oncology, Galway

Mid Western Regional Hospital, Limerick

Waterford Regional Hospital, Waterford

Dublin 7

Mater Misericordiae University Hospital, Dublin

00128

Istituti Fisioterapici Ospitalieri, Roma

03039

Ospedale SS Trinita, Sora (FR)

464-8681

Aichi Cancer Center Hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

791-0280

National Hospital Organization Shikoku Cancer Center, Matsuyama

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

862-8505

Kumamoto City Hospital, Kumamoto

362-0806

Saitama Cancer Center, Kita-adachi-gun

104-0045

National Cancer Center Hospital, Chuo-Ku

260-8717

Chiba Cancer Center, Chiba

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

892-0833

Hakuaikai Medical Corporation Sagara Hospital, Kagoshima

860-8556

Kumamoto University Hospital, Kumamoto

951-8566

Niigata Cancer Center Hospital 2-15-3, Niigata

020-8505

Iwate Medical University Hospital, Numakunai

540-0006

National Hospital Organization Osaka National Hospital, Osaka

05-400

Europejskie Centrum Zdrowia Otwock, Otwock

80-214

Oncology and Radiotherapy Clinic, Gdansk

44-240

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

03722

Severance Hospital, Yonsei University Health System, Seodaemun-gu

03080

Seoul National University Hospital / Department of Internal Medicine, Seoul

05505

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

06351

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

07010

Hospital Universitari Son Espases, Palma de Mallorca

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08227

Consorci Sanitari de Terrassa, Terrassa

06080

Hospital Universitario Infanta Cristina, Badajoz

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic I Provincial, Barcelona

08908

Instituto Catalan de Oncologia L'Hospitalet, L'Hospitalet de Llobregat (Barcelona)

ME16 9QQ

Kent Oncology Center, Maidstone

EH4 2XU

Edinburgh Cancer Centre, Western General Hospital, Edinburgh

G12 0YN

Beatson Institute for Cancer Research, Glasgow

SE1 9RT

Guys Hospital, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

W6 8RF

Charing Cross Hospital, London

M20 4BX

Christie Hospital NHS Foundation Trust, Manchester

M204BX

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01740427 - A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) | Biotech Hunter | Biotech Hunter