Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01740427
First received: November 26, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: PD-0332991
Drug: Letrozole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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,

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.


Secondary Outcome Measures:
  • Probability of Participant Survival [ Time Frame: From start of study treatment up to 6 years ] [ Designated as safety issue: Yes ]
    Probability of survival 1-year, 2- and 3-years after the first dose of study treatment

  • Overall Survival (OS) [ Time Frame: Baseline to date of death from any cause (up to 6 years) ] [ Designated as safety issue: Yes ]
    Time from date of randomization to date of death due to any cause.

  • Objective Response (OR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    OR is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause.

  • Duration of Response (DR) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer.

  • Disease Control (DC) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    DC is defined as complete response (CR), partial response (PR), or stable disease (SD) ≥24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.

  • QTc interval [ Time Frame: Baseline and Day 14 of Cycle 1 ] [ Designated as safety issue: Yes ]
    Time between the start of the Q wave and the end of the T wave corrected for heart rate.

  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 14 of cycles 1 and 2 ] [ Designated as safety issue: No ]
    Minimum Observed Plasma Trough Concentration (Cmin)

  • Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Instrument designed to assess health status in terms of a single index value or utility score.

  • Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) at Week X [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]
    Instrument designed to assess patient concerns relating to breast cancer

  • Tumor tissue biomarkers [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Tumor tissue biomarkers will be analyzed to investigate possible associations with resistance/sensitivity to treatment with study drugs. Biomarkers that will be analyzed will be selected based on their known relevance to mechanisms involved in cell cycle regulation.


Estimated Enrollment: 650
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PD-0332991 + Letrozole
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Drug: PD-0332991
PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Drug: Letrozole
Letrozole, 2.5mg, orally once daily (continuously)
Active Comparator: Placebo + Letrozole
Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).
Drug: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Confirmed diagnosis of HER2 positive disease
  • Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
  • Known uncontrolled or symptomatic CNS metastases
  • Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
  • Prior treatment with any CDK 4/6 inhibitor.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740427

  Hide Study Locations
Locations
United States, California
UCLA Hematology Oncology
Alhambra, California, United States, 91801
Southern California Kaiser Medical Center - Bellflower Medical Offices
Bellflower, California, United States, 90706
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
St. Jude Heritage Healthcare - Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
UCLA/TRIO US Network
Irvine, California, United States, 92604
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-1772
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Translational Research Management
Los Angeles, California, United States, 90045
TRIO-US Central Administration
Los Angeles, California, United States, 90095
TRIO-US Central Administration: Regulatory Management Only
Los Angeles, California, United States, 90095
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
UCLA School of Medicine
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-7349
Los Angeles Hematology/Oncology Medical Group
Los Angeles, California, United States, 90017
UCLA West Medical Pharmacy, Attn: Steven L. Wong
Los Angeles, California, United States, 90095-7349
UCLA West Medical Pharmacy: Drug Management Only
Los Angeles, California, United States, 90095-7349
Westwood Bowyer Clinic
Los Angeles, California, United States, 90095
UCLA/Pasadena HealthCare
Pasadena, California, United States, 91105
UCLA Hematology Oncology-Porter Ranch
Porter Ranch, California, United States, 91326
Cancer Care Associates Medical Group, INC.
Redondo Beach, California, United States, 90277
University of California, San Francisco
San Francisco, California, United States, 94115
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, United States, 90404
UCLA Hematology Oncology Santa Monica
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center and Orthopaedic Hospital
Santa Monica, California, United States, 90404
Stanford Women's Cancer Center
Stanford, California, United States, 94304-5826
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, United States, 91355
Wellness Oncology & Hematology
West Hills, California, United States, 91307
UCLA Cancer Center
Westlake Village, California, United States, 91361
United States, Colorado
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Smilow Cancer Center at Yale New Haven
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Whittingham Cancer Center @ Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami
Deerfield, Florida, United States, 33442
Memorial Cancer Institute East
Hollywood, Florida, United States, 33021
Memorial Cancer Institute/Breast Cancer Center
Hollywood, Florida, United States, 33021
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Cancer Specialist of North Florida
Jacksonville, Florida, United States, 32256
Cancer Specialist of North Florida/Baptist Medical Center- downtown
Jacksonville, Florida, United States, 32207
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Memorial Cancer Institute
Pembroke Pines, Florida, United States, 33028
Memorial Cancer Institute West
Pembroke Pines, Florida, United States, 33028
Memorial Hospital WEST
Pembroke Pines, Florida, United States, 33028
University of Miami
Plantation, Florida, United States, 33324
Cancer Specialist of North Florida/St. Augustine
St. Augustine, Florida, United States, 32086
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Grady Health System
Atlanta, Georgia, United States, 30303
Investigational Drug Service
Atlanta, Georgia, United States, 30322
Winship Cancer Institute, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Centers, P.C.
Austell, Georgia, United States, 30106
Northwest Georgia Oncology Centers, P.C
Carrolton, Georgia, United States, 30117
Northwest Georgia Oncology Centers, P.C
Cartersville, Georgia, United States, 30121
Northwest Georgia Oncology Centers P.C.
Douglasville, Georgia, United States, 30134
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Idaho
Kootenai Clinic Cancer Services
Coeur d'Alene, Idaho, United States, 83814
Kootenai Clinic Cancer Services
Post Falls, Idaho, United States, 83854
United States, Illinois
Presence Saint Joseph Hospital
Chicago, Illinois, United States, 60657
North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois, United States, 60014
Carle Foundation Hospital DBA Carle Cancer Center
Danville, Illinois, United States, 61832
Carle Foundation Hospital DBA Carle Cancer Center
Effingham, Illinois, United States, 62401
North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois, United States, 60048
Carle Foundation Hospital DBA Carle Cancer Center
Mattoon, Illinois, United States, 61938
Presence Medical Group Hematology Oncology
Northbrook, Illinois, United States, 60062
Presence Medical Group Hematology Oncology
Skokie, Illinois, United States, 60077
Carle Foundation Hospital DBA Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kentucky
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
James Graham Brown Cancer Center and University Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
United States, Michigan
U of M Internal Medicine Oncology
Ann Arbor, Michigan, United States, 48109
University of Michigan Health System
Ann Arbor, Michigan, United States, 48100
United States, Minnesota
Park Nicollet Frauenshuh Cancer Center
St. Louis Park, Minnesota, United States, 55426
United States, Mississippi
The West Clinic, PC
Corinth, Mississippi, United States, 38834
The West Clinic, PC
Southaven, Mississippi, United States, 38671
United States, Missouri
Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin, Missouri, United States, 63011
Mercy Clinic St. Louis Cancer and Breast Institute
St. Louis, Missouri, United States, 63109
Mercy Hospital St. Louis
St. Louis, Missouri, United States, 63141
St. John's Mercy, David C. Pratt Cancer Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, United States, 68803
Saint Francis Medical Center
Grand Island, Nebraska, United States, 68803
Saint Frances Medical Center
Hastings, Nebraska, United States, 68901
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada Research Department
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
United States, New York
Mount Kisco Medical Group
Brewster, New York, United States, 10549
Mount Kisco Medical Group
Mount Kisco, New York, United States, 10549
Northern Westchester Hospital
Mt Kisco, New York, United States, 10549
CUMC Herbert Irving Pavilion
New York, New York, United States, 10032
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-9447
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97213
OHSU Center for Health and Healing
Portland, Oregon, United States, 97239
OHSU Research Pharmacy Services
Portland, Oregon, United States, 97239
Kaiser Permanente Northwest Region
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States, 97062
United States, Tennessee
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology PLLC
Hermitage, Tennessee, United States, 37076
Tennessee Oncology PLLC
Lebanon, Tennessee, United States, 37087
The West Clinic, PC
Memphis, Tennessee, United States, 38104
The West Clinic, PC
Memphis, Tennessee, United States, 38120
Tennessee Oncology PLLC
Murfreesboro, Tennessee, United States, 37129
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37211
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37207
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Smryna, Tennessee, United States, 37167
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology-El Paso Cancer Treatment Center Grandview
El Paso, Texas, United States, 79902
Texas Oncology-El Paso Cancer Treatment Center Joe Battle
El Paso, Texas, United States, 79938
Texas Oncology- El Paso Cancer Treatment Center Gateway
El Paso, Texas, United States, 79915
Investigational Products Center (IPC)
Fort Worth, Texas, United States, 76177
US Oncology Research and Clinical Pharmacy (Drug Shipment Only)
Fortworth, Texas, United States, 76177
Investigational Products Center (IPC)
Fortworth, Texas, United States, 76177
The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
Houston, Texas, United States, 77030-4009
United States, Virginia
Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
Blacksburg, Virginia, United States, 24060
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Low Moor, Virginia, United States, 24457
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Shenandoah Oncology, P.C.
Winchester, Virginia, United States, 22601
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Wytheville, Virginia, United States, 24382
United States, Washington
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98034
Seattle Cancer Care Alliance at Evergreen Health
Kirkland, Washington, United States, 98034
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Northwest Cancer Specialists P.C.
Vancouver, Washington, United States, 98684
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98683
United States, West Virginia
West Virginia University - Department of Medicine
Morgantown, West Virginia, United States, 26506-9162
West Virginia University Hospitals
Morgantown, West Virginia, United States, 25606
United States, Wisconsin
UW Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Kinghorn Cancer Centre / St Vincent's Hospital (Sydney) Pty Ltd
Darlinghurst, New South Wales, Australia, 2010
North Coast Cancer Institute/Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2310
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Princess Alexandra Hospital
Wooloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Bendigo Health Care Group, The Bendigo Hospital Campus
Bendigo, Victoria, Australia, 3550
Day Oncology, Northern Hospital
Epping, Victoria, Australia, 3076
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Epworth Hospital
Richmond, Victoria, Australia, 3121
Maroondah Hospital
Ringwood East, Victoria, Australia, 3135
Goulburn Valley Health
Shepparton, Victoria, Australia, 3630
Australia, Western Australia
Royal Perth Hospital, Department of Medical Oncology
Perth, Western Australia, Australia, 6000
Belgium
GZA ziekenhuizen Campus, Sint-Augustinusziekenhuis
Wilrijk, Antwerpen, Belgium, 2610
UZ Brussel
Brussel, Belgium, 1090
Institut Jules Bordet
Brussels, Belgium, 1000
Oncologie
Brussels, Belgium, 1200
Grand Hopital de Charleroi / Service d'Hematologie et Oncologie
Charleroi, Belgium, 6000
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
CHU Start Tilman
Liege, Belgium, 4000
Centre Hospitalier Peltzer - La Tourelle, Service de Cancerologie
Verviers, Belgium, 4800
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BC Cancer Agency-Fraser Valley Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency-Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
QEII Health Sciences Centre, Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
QEII Health Sciences Centre, Victoria General Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
London Health Sciences Centre, Victoria Hospital
London, Ontario, Canada, N6A 4G5
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Southlake Regional Health Centre / Stronach Regional Cancer Centre
Newmarket, Ontario, Canada, L3Y2P9
Princess Margaret Hospital - University Health Network
Toronto, Ontario, Canada, M5G 2M9
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
St. Mary's Hospital
Montreal, Quebec, Canada, H3T 1M5
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Hopital du Sacre-Coeur
Montreal, Quebec, Canada, H4JIC5
Center Hospitalier Affilie Universitaire de Quebec, Hopital du Saint Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Czech Republic
Compr Cancer Ctr of University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
France
Institut de Cancerologie de I'Ouest-Paul Papin
Angers Cedex 9, France, 49933
Centre François Baclesse
Caen Cedex 5, France, 14076
Centre Georges François Leclerc
Dijon Cedex, France, 21079
Centre hospitalier Departemental les Oudairies
La Roche-Sur-Yon, France, 85025
Centre Val d'Aurelle,
Montpellier CEDEX 5, France, 34298
Centre Antoine Lacassagne
Nice cedex 2, France, 06189
Institut Curie, Departement d'Oncologie Medicale
Paris Cedex 05, France, 75248
Centre Eugene Marquis
Rennes, France, 35062
Hopital Rene Huguenin/Institut Curie
Saint-Cloud, France, 92210
Centre Rene Gauducheau
St Herblain, France, 44805
Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department
Toulouse CEDEX-9, France, 31059
Institut Gustave Roussy
Villejuif, France, 94805
Germany
University of Kiel
Kiel, SH, Germany, 24105
Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen
Boeblingen, Germany, 71032
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Universitaetsklinikum Erlangen, Frauenklinik
Erlangen, Germany, 91054
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Universitaetsklinikum Magdeburg A.oe.R.
Magdeburg, Germany, 39108
Katholisches Klinikum Mainz
Mainz, Germany, 55131
Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen
Muenchen, Germany, 81675
Onkologische Praxis Muenchen
Muenchen, Germany, 80336
Rotkreuzklinikum Munchen Gmbh
Munchen, Germany, 80637
Breast Cancer, University of Munich, Grosshadern Hospital
Munich, Germany, 81377
Mutterhaus der Borromaeerinnen, Innere Medizin I
Trier, Germany, 54290
Hungary
Országos Onkológiai Intézet
Budapest, Hungary, 1122
Szent Margit Korhaz Onkologia
Budapest, Hungary, 1032
Diagnoscan Magyarorszag Kft.
Gyor, Hungary, 9024
Petz Aladar Megyei Oktato Korhaz
Gyor, Hungary, 9024
Petz Aladar Megyei Oktato Korhaz, Onkoradiologia
Gyor, Hungary, 9024
Josa Andras Hospital
Nyiregyhaza, Hungary, 4400
Szegedi Egyetem Onkologiai Klinika
Szeged, Hungary, 6720
Diagnoscan Magyarorszag Kft.
Szeged, Hungary, 6725
Ireland
Bon Secours Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland, 9
Mater Misericordiae University Hospital
Dublin, Ireland, Dublin 7
St Vincents University Hospital
Dublin 4, Ireland
Department of Medical Oncology
Galway, Ireland
Waterford Regional Hospital
Waterford, Ireland
Italy
Irccs Irst
Meldola, Forli, Italy, 47014
IRCCS - Istituto Europeo di Oncologia
Milano, Milan, Italy, 20141
Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
Istituto Regina Elena - Struttura Complessa Oncologia Medica A
Roma, Italy, 00144
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Saitama Cancer Center
Kita-adachi-gun, Saitama, Japan, 362-0806
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
Chiba Cancer Center
Chiba, Japan, 260-8717
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Hiroshima City Hiroshima Citizens Hospita
Hiroshima, Japan, 730-8518
Iwate Medical University Hospital
Iwate, Japan, 020-8505
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Japan, 892-0833
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kumamoto City Hospital
Kumamoto, Japan, 862-8505
Niigata Cancer Center Hospital 2-15-3
Niigata, Japan, 951-8566
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Korea, Republic of
National Cancer Center, Center for Breast Cancer
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Severance Hospital, Yonsei University Health System
Seodaemun-Gu, Seoul, Korea, Republic of, 120-725
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Seoul, Korea, Republic of, 138-736
Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital / Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Europejskie Centrum Zdrowia Otwock
Otwock, Poland, 05-400
Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian
Zory, Poland, 44-240
Russian Federation
Regional Budgetary Healthcare Institution Kursk Regional Clinical
Kursk, Kursk Region, Russian Federation
Federal State Budget Institution
Moscow, Russian Federation, 115478
City Oncology Clinical Hospital #62, Chemotherapy Department
Moscow, Russian Federation, 143423
State Budget Institution of Healthcare
Omsk, Russian Federation, 644046
State Budget Institution of Healthcare
Omsk, Russian Federation, 644013
Ryazan Regional Clinical Oncology Dispensary
Ryazan, Russian Federation, 390011
State educational institution of higher education "Ryazan State Medical University named after IP Pa
Ryazan, Russian Federation, 390026
Saint-Petersburg State Budget Healthcare Institution (SBHCI)
Saint-Petersburg, Russian Federation, 197022
Non-state institution of Healthcare "Railway Clinical Hospital at OJSC "RR"
St. Petersburg, Russian Federation, 195271
State Budget Medical Institution Republican Clinical Oncology
Ufa, Russian Federation, 450054
SHBI of Republic of Bashkortostan Emergency Hospital
Ufa, Russian Federation, 450106
Republican Clinical Hospital n.a. G.G. Kuvatov
Ufa, Russian Federation, 450005
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital Universitari Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Universitario Fundacion de Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06080
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital de Donostia
Donostia- San Sebastian, Spain, 20014
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Instituto Catalan de Oncologia L'Hospitalet
L'Hospitalet de Llobregat (Barcelona), Spain, 08908
Centro Oncologico de Galicia
La Coruna, Spain, 15009
Hospital Universitario de Canarias
La Laguna (Santa Cruz de Tenerife), Spain, 38320
Hospital Universitario Arnau De Vilanova de Lleida
Lleida, Spain, 25198
Centro Oncologico MD Anderson Internacional España
Madrid, Spain, 28033
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Madrid Universitario Sanchinarro
Madrid, Spain, 28050
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Taiwan
Veterans General Hospital-Taipei
Taipei, ROC, Taiwan, 112
Mackay Memory Hospital
Taipei, Taiwan, 10449
National Taiwan University Hospital
Taipei, Taiwan, 106
Ukraine
Municipal Institution "City Multi-field Clinical Hospital #4 of Dnipropetrovsk Regional Council"
Dnipropetrovsk, Ukraine, 49102
Kharkiv Regional Clinical Oncology Hospital
Kharkiv, Ukraine, 61070
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
Makiivka City Hospital n2 of Donetsk Region
Makiivka, Ukraine, 86120
Sumy Regional Clinical Oncology Dispensary
Sumy, Ukraine, 40005
Institute of Postgraduate education and preuniversity preparing of Uzhgorod National University
Uzhgorod, Ukraine, 88000
Zaporizhzhia Regional Clinical Oncology Dispensary
Zaporizhzhya, Ukraine, 69040
United Kingdom
Kent Oncology Department
Maidstone, Kent, United Kingdom, ME16 9QQ
Medical Oncology, Christie Hospital
Withington, Manchester, United Kingdom, M20 4BX
Beatson Institute for Cancer Research
Glasgow, Scotland, United Kingdom, G12 0YN
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Imperial Healthcare NHS Trust- Charing Cross Hospital
London, United Kingdom, W6 8RF
The Royal Marsden NHS Foundation
London and Sutton, United Kingdom, SW3 6JJ and SM2 5PT
The Research And Development Office, The Christie NHS Foundation Trust
Manchester, United Kingdom, M204BX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01740427     History of Changes
Other Study ID Numbers: A5481008, 2012-004601-27
Study First Received: November 26, 2012
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
breast cancer
postmenopausal women
estrogen-receptor positive
HER2 negative
locoregionally recurrent
metastatic
Palbociclib (PD-0332991)
PALOMA-2

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014