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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01942135
First received: September 10, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Palbociclib
Drug: Fulvestrant
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)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Of Fulvestrant (Faslodex®) With Or Without PD-0332991 (Palbociclib) +/- Goserelin In Women With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Baseline up to approximately 10 months ] [ Designated as safety issue: No ]
    Time from randomization to the first documentation of objective tumor progression or to death due to any cause.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Baseline until death (up to approximately 28 months) ] [ Designated as safety issue: No ]
    Time from randomization to date of death due to any cause.

  • Objective Response [ Time Frame: Baseline until approximately 10 months ] [ Designated as safety issue: No ]
    Complete or partial response recorded from randomization until disease progression or death due to any cause.

  • Duration of Response [ Time Frame: Baseline up to approximately 10 months ] [ Designated as safety issue: No ]
    Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause.

  • Clinical Benefit Response (CBR) [ Time Frame: Baseline up to approximately 10 months ] [ Designated as safety issue: No ]
    CBR is defined as complete response or partial response or stable disease equal to or greater than 24 weeks according to RECIST version 1.1 recorded in the time period between randomization and disease progression or death of any cause.

  • 1 Year Probability of Participant Survival [ Time Frame: From baseline through 1 year ] [ Designated as safety issue: No ]
    Probability of survival one year after randomization.

  • 2 Year Probability of Participant Survival [ Time Frame: From baseline through 2 years ] [ Designated as safety issue: No ]
    Probability of survival 2 years after randomization

  • 3 Year Probability of Participant Survival [ Time Frame: From baseline through 3 years ] [ Designated as safety issue: Yes ]
    Probability of survival 3 years after randomization.

  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Cycles 1 and 2 ] [ Designated as safety issue: No ]
    Cmin for palbociclib, fulvestrant and goserelin (if applicable)

  • Alterations in genes, proteins, and ribonucleic acids relevant to the cell cycle, drug targets, tumor sensitivity and/or resistance [ Time Frame: From baseline until approximately 10 months ] [ Designated as safety issue: No ]
    Biomarkers from tissue including genes, proteins, and RNA expression

  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: From baseline through approximately month 10 ] [ Designated as safety issue: No ]
    EQ 5D (version 3L) is a 6 item instrument designed to assess health status in terms of a single index value or utility score.

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [ Time Frame: From baseline through approximately month 10 ] [ Designated as safety issue: No ]
    The EORTC QLQ C30 is a 30 item questionnaire composed of functional subscales; symptom scales; and other cancer related symptoms.

  • European Organization for Research and Treatment of Cancer breast cancer module (EORTC QLQ BR23) [ Time Frame: From baseline through approximately month 10 ] [ Designated as safety issue: No ]
    EORTC QLQ BR23 is a 23 item breast cancer specific companion module to the EORTC QLQ C30.

  • Time to Deterioration (TTD) [ Time Frame: From baseline through approximately month 10 ] [ Designated as safety issue: No ]
    Time from randomization to the first documentation of objective tumor progression, death due to any cause, and/or reduction in quality of life

  • Minimally Important Difference Cut-Off [ Time Frame: From baseline through approximately month 10 ] [ Designated as safety issue: No ]
    Number of time points where the minimally importance difference in QoL is achieved


Estimated Enrollment: 417
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Drug: Palbociclib
Palbociclib 125 mg/day orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Drug: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.
Active Comparator: Arm B
Given until objective progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first.
Drug: Placebo
Placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle.
Drug: Fulvestrant
Fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28 day cycle.

  Eligibility

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

Inclusion Criteria:

  • Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
  • Confirmed diagnosis of HR+/HER2- breast cancer
  • Any menopausal status
  • Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy
  • On an LHRH agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization.
  • Measurable disease defined by RECIST version 1.1, or bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) PS 0-1
  • Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
  • Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

  • Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
  • Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
  • Major surgery or any anti-cancer therapy within 2 weeks of randomization
  • Prior stem cell or bone marrow transplantation
  • Use of potent CYP3A4 inhibitors or inducers
  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: NCT01942135

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
UAB Hospital-Investigational Drug Service
Birmingham, Alabama, United States, 35249
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
Southern Cancer Center
Mobile, Alabama, United States, 36608
Southern Cancer Center, PC
Mobile, Alabama, United States, 36607
United States, Arizona
Arizona Center for Cancer Care
Avondale, Arizona, United States, 85323
Ironwood Cancer and Research Centers, PC
Chandler, Arizona, United States, 85224
Arizona Oncology Associates, PC- NAHOA
Flagstaff, Arizona, United States, 86002
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC
Gilbert, Arizona, United States, 85297
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC
Mesa, Arizona, United States, 85202
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC
Mesa, Arizona, United States, 85206
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC
Phoenix, Arizona, United States, 85028
Arizona Oncology Associates, PC- NAHOA
Prescott Valley, Arizona, United States, 86314
21st Century Oncology
Scottsdale, Arizona, United States, 85251
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Arizona Oncology Associates, PC- NAHOA
Sedona, Arizona, United States, 86336
Arizona Center for Cancer Care
Surprise, Arizona, United States, 85374
The University of Arizona Cancer Center- North Campus
Tucson, Arizona, United States, 85719
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA Hematology Oncology
Alhambra, California, United States, 91801
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
City of Hope
Duarte, California, United States, 91010
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Global Research Management
Glendale, California, United States, 91204
UCLA Hematology Oncology
Irvine, California, United States, 92604
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
UC San Diego Medical Center-La Jolla
La Jolla, California, United States, 92037
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
UC San Diego Moores Cancer Center-Investigational Drug Services
La Jolla, California, United States, 92037-0845
Breastlink Medical Group, Inc.
Long Beach, California, United States, 90806
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-7349
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Hematology-Oncology
Los Angeles, California, United States, 90095
Administrative Management Only
Los Angeles, California, United States, 90045
TRIO- US Central Administration
Los Angeles, California, United States, 90095
Administrative Management Only: Translational Research Management
Los Angeles, California, United States, 90045
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095
Regulatory Management Only: TRIO-US Central Adminstration
Los Angeles, California, United States, 90095
Drug shipment only: Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
CRU Administrative Office: UCLA Hematology Oncology
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic
Los Angeles, California, United States, 90095
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC & USC Medical Center
Los Angeles, California, United States, 90033
North County Oncology Medical
Oceanside, California, United States, 92056
North Country Oncology
Oceanside, California, United States, 92056
Breastlink Medical Group, Inc.
Orange, California, United States, 92868
Medical Oncology Care Associates (MOCA)
Orange, California, United States, 92868
St. Joseph's Hospital / The Center for Cancer Prevention and Treatment
Orange, California, United States, 92868
St. Joseph Hospital Pharmacy Department (Drug Shipment Only)
Orange, California, United States, 92868
Hematology-Oncology Medical Group of Orange County (HOMG)
Orange, California, United States, 92868
UCLA/Pasadena HealthCare
Pasadena, California, United States, 91105
UCLA Hematology Oncology-Porter Ranch
Porter Ranch, California, United States, 91326
Cancer Care Associates Medical Group
Redondo Beach,, California, United States, 90281
UC San Diego Medical Center-Hillcrest
San Diego, California, United States, 92103
UCSF Medical Center-Mt. Zion/Pharmaceutical Services
San Francisco, California, United States, 94115
University of California, San Francisco: Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94115
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
Edward Alexson, MD, Inc.
Santa Ana, California, United States, 92705
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Santa Monica Medical Center and Orthopaedic Hospital
Santa Monica, California, United States, 90404
UCLA Hematology Oncology Santa Monica-Parkside
Santa Monica, California, United States, 90404
UCLA Hematology Oncology Santa Monica
Santa Monica, California, United States, 90404
City of Hope Medical Group
South Pasadena, California, United States, 91030
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, United States, 91105
Wellness Oncology & Hematology
West Hills, California, United States, 91307
UCLA Westlake Village Hermatology Oncology
Westlake Village, California, United States, 91361
United States, Colorado
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
University of Colorado Cancer Center (Drug Shipment Only)
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami Hospital and Clinics (UHMC) Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Holy Cross Hospital-Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, United States, 33308
University of Florida Health Shands Hospitals
Gainesville, Florida, United States, 32610
University of Florida Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608
Davis Cancer Pavilion and Shands Medical Plaza
Gainesville, Florida, United States, 32608
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Cancer Institute East
Hollywood, Florida, United States, 33021
TRIO -US Central Administration
Los Angeles, Florida, United States, 90095
UCLA West Medical Pharmacy
Los Angles, Florida, United States, 90095-7349
Sylvester Comprehensive Cancer Center/ University of Miami Hospital and Clinics (UHMC)
Miami, Florida, United States, 33136
University of Miami Hospital
Miami, Florida, United States, 33136
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
MSMC CCOP, Research Pharmacy
Miami Beach, Florida, United States, 33140
Orlando Health, Inc
Orlando, Florida, United States, 32806
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Memorial Cancer Institute West
Pembroke Pines, Florida, United States, 33028
University of Miami Hospital and Clinics (UHMC) Sylvester at Plantation
Plantation, Florida, United States, 33324
United States, Georgia
Ann Johnston
Atlanta, Georgia, United States, 30318
Northwest Georgia Oncology Centers, P.C.
Austell, Georgia, United States, 30106
Northwest Georgia Oncology Centers, PC
Carrollton, Georgia, United States, 30117
Northwest Georgia Oncology Centers, PC
Cartersville, Georgia, United States, 30121
Northwest Georgia Oncology Centers, PC
Douglasville, Georgia, United States, 30134
Piedmont Cancer Institute, PC
Fayetteville, Georgia, United States, 30214
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Illinois
Rush-Copley Medical Center
Aurora, Illinois, United States, 60504
Rush University Medical Center
Chicago, Illinois, United States, 60612
Rush-Copley Healthcare Center
Yorkville, Illinois, United States, 60560
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Kansas
University of Kansas Cancer Center (Research Office)
OVerland Park, Kansas, United States, 66210
University of Kansas Cancer Center
Overland Park, Kansas, United States, 66210
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine & Blood Disorders
Sanford, Maine, United States, 04073
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, United States, 04074
Maine Center For Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
Lutherville, Maryland, United States, 21093
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, United States, 49503
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
Cancer & Hematology Centers of Western Michigan, PC
Holland, Michigan, United States, 49424
United States, Minnesota
Fairview Southdale Oncology Clinic
Edina, Minnesota, United States, 55435
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455
Drug Shipment Address: University of Minnesota Medical Center, Fairview IDS Pharmacy
Minneapolis, Minnesota, United States, 55455
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin, Missouri, United States, 63011
Kansas City Cancer Center
Kansas City, Missouri, United States, 64111
University of Kansas Cancer Center
Kansas City, Missouri, United States, 64131
University of Kansas Cancer Center
Kansas City, Missouri, United States, 64154
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States, 63110
Mercy Clinic St. Louis Cancer and Breast Institute
St. Louis, Missouri, United States, 63109
Barnes- Jewish Hospital
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Mercy Hospital St.Louis-David C. Pratt Cancer Center
St. Louis, Missouri, United States, 63141
Siteman Cancer Center- West County
St. Louis, Missouri, United States, 63110
Mercy Hospital St. Louis
St. Louis, Missouri, United States, 63141
Siteman Cancer Center- South County
St. Louis, Missouri, United States, 63129
United States, Nevada
Comprehensive Cancer Centers of Nevada Research Department
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 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 Jersey
Rtugers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
United States, New York
Mount Kisco Medical Group
Brewster, New York, United States, 10509
ProHEALTH Care Associates, LLP
Lake Success, New York, United States, 11042
Anh Phung
Mount Kisco, New York, United States, 10549
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
United States, North Carolina
Hope Women's Cancer Centers
Asheville, North Carolina, United States, 28806
Mission Hospital, Inc.
Asheville, North Carolina, United States, 28806
United States, Ohio
Toledo Clinic Cancer Center - Toledo
Toledo, Ohio, United States, 43623
Toledo Community Oncology Program
Toledo, Ohio, United States, 43617
The University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Oregon
North Bend Medical Center Inc.
Coos Bay, Oregon, United States, 97420
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
UPMC Cancer Center, Monroeville
Monroeville, Pennsylvania, United States, 15146
Thomas Jefferson University, Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Universsity of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Guthrie Clinic, LTD
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
United States, Texas
The Center for Cancer and Blood Disorders
Arlington, Texas, United States, 76104
The Center for Cancer and Blood Disorders
Burleson, Texas, United States, 76028
Texas Oncology- Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Investigational Products Center (IPC) (Durg Shipment Only)
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC), (Druh Shipment Only)
Fort Worth, Texas, United States, 76177
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States, 76104
Investigational Products Center (IPC) (Drug Shipment Only)
Fort Worth, Texas, United States, 76177
Memorial Hermann Hospital- TMC
Houston, Texas, United States, 77030
Memorial Hermann Hospital - TMC
Houston, Texas, United States, 77030
UT/Memorial Hermann Cancer Center
Houston, Texas, United States, 77030
Texas Oncology- Longview Cancer Center
Longview, Texas, United States, 75601
South Texas Cancer Center
McAllen, Texas, United States, 78503
Texas Oncology- McAllen South Second Street
McAllen, Texas, United States, 78503
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78212
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78258
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
The Center for Cancer and Blood Disorders
Weatherford, Texas, United States, 76086
Texas Oncology- Weslaco
Weslaco, Texas, United States, 78596
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22205
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22903
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Medical Oncology & Hematology Associates of Northern Virginia, LTD
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Leesburg, Virginia, United States, 20176
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Medical Oncology & Hematology Associates of Northern Virginia
Reston, Virginia, United States, 20190
Virginia Oncology Associates
Virginia Beach, Virginia, United States, 23456
Shenandoah Oncology
Winchester, Virginia, United States, 22601
United States, Washington
Swedish Medical Center Investigational Drug Services
Seattle, Washington, United States, 98122
Swedish Medical Center
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Julie Hugg
Mequon, Wisconsin, United States, 53097
Columbia St. Mary's
Milwaukee, Wisconsin, United States, 53211
Australia, New South Wales
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Australia, Queensland
Nambour General Hospital
Nambour, Queensland, Australia, 4560
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Western Health/Medical Oncology and Hematolog
Footscray, Victoria, Australia, 3011
Western Health, The Western Hospital
Footscray, Victoria, Australia, 3011
Frankston Hospital/Peninsula Oncology Centre
Frankston, Victoria, Australia, 3199
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Royal Perth Hospital/Medical Oncology
Perth, Western Australia, Australia, 6000
Australia
Bankstown - Lidcombe Hospital
Bankstown, Australia, 2200
Cabrini Brighton
Brighton, Australia, 3186
Monash Cancer Centre
East Bentleigh, Australia, 3165
Cabrini Hospital
Malvern, Australia, 3144
Icon Cancer Care Southport
Southport, Australia, 4215
Peter MacCallum Cancer Centre Ethics Committee
Victoria, Australia, 8006
Belgium
UZ Antwerpen/ Oncologie
Edegem, Antwerpen, Belgium, 2650
Clinique St Pierre
Ottignies, Brabant Wallon, Belgium, 1340
Grand Hôpital de Charleroi - Site Notre Dame / Oncologie - Hématologie
Charleroi, Hainaut, Belgium, 6000
Centre Hospitalier Jolimont
Haine St. Paul, Hainaut, Belgium, 7100
Chaussée de Saint-Amand 80
Tournai, Hainaut, Belgium, 7500
Queen's University - Kingston General Hospital
Kingston, ON, Belgium, K7L 5P9
Clinique Ste Elisabeth /
Roselare, West-Vlaanderen, Belgium, 8800
Imelda Ziekenhuis / Oncology
Bonheiden, Belgium, 2820
C.H.U. Brugmann, Hematologie
Brussels, Belgium, 1020
Jules Bordet Institute-Medical Oncology Clinic
Bruxelles, Belgium, 1000
Cliniques Universitaires Saint-Luc/Oncologie Médicale
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
C.H. de l'Ardenne
Libramont, Belgium, 6800
CHU de Liège/ Oncologie Médicale
Liège, Belgium, 4000
Clinique Ste Elisabeth / Oncologie
Namur, Belgium, 5000
AZ Nikolaas
Sint-Niklaas, Belgium, 9100
Sint Augustinusziekenhuis Wilrijk / Medical Oncology
Wilrijk, Belgium, 2610
Canada, British Columbia
Carol Winn
Kelowna, British Columbia, Canada, V1Y 5L3
B.C. Cancer Agency, Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1h 8L6
Niagara Health System - Walker Family Cancer Centre
St. Catharines, Ontario, Canada, L2S 0A9
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital (JGH Oncology)
Montreal, Quebec, Canada, H3T 1E2
McGill University, Clinical Research Program
Montreal, Quebec, Canada, H2W 1S6
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
St. Mary's Hospital
Montreal, Quebec, Canada, H3T 1M5
Germany
Pfizer Investigational Site
Kiel, SH, Germany, D-24105
Pfizer Investigational Site
Berlin, Germany, 10967
Pfizer Investigational Site
Kiel, Germany, 24103
Pfizer Investigational Site
Kiel, Germany, 24105
Pfizer Investigational Site
Köln, Germany, 50931
Pfizer Investigational Site
Leipzig, Germany, 04103
Pfizer Investigational Site
München, Germany, 80337
Ireland
Bon Secours Hospital
Cork, Ireland
Beaumont Hospital, Cancer Clinical Trials & Research Unit
Dublin, Ireland, Dublin 9
St James's Hospital
Dublin, Ireland, Dublin 8
Sligo General Hospital
Sligo, Ireland
Italy
Pfizer Investigational Site
Bagno a Ripoli (FI), Firenze, Italy, 50012
Pfizer Investigational Site
Legnago, Verona, Italy, 37045
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Catania, Italy, 95123
Pfizer Investigational Site
Meldola (FC), Italy, 47014
Pfizer Investigational Site
Milano, Italy, 20133
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Milano, Italy, 20132
Pfizer Investigational Site
Modena, Italy, 41100
Pfizer Investigational Site
Napoli, Italy, Via Mariano Semmola
Pfizer Investigational Site
Palermo, Italy, 90127
Pfizer Investigational Site
Roma, Italy, 00189
Pfizer Investigational Site
Roma, Italy, 00144
Pfizer Investigational Site
Roma, Italy, 00168
Pfizer Investigational Site
Roma, Italy, 00161
Pfizer Investigational Site
Terni, Italy, 05100
Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Matsuyama-city, Ehime, Japan
Pfizer Investigational Site
Kita-adachi-gun, Saitama, Japan
Pfizer Investigational Site
Aichi, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Kagoshima, Japan
Pfizer Investigational Site
Osaka, Japan
Korea, Republic of
Seoul National University Bundang Hospital, Hematology-oncology
Seongnam, Gyunggido, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Republic of Korea, Korea, Republic of, 110-744
Samsung Medical Center [Hematology-Oncology]
Gangnam-gu, Seoul, Korea, Republic of, 135-710
National Cancer Center, Center for Breast Cancer
Goyang, Korea, Republic of, 410-769
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan medical Center
Seoul, Korea, Republic of, 138-736
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Leiden University Medical Center/ Clinical Oncology
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Haga Ziekenhuis, loc. Leyenburg / Internal Medicine
Den Haag, Netherlands, 2545 CH
Ikazia Ziekenhuis / Internal medicine
Rotterdam, Netherlands, 3083 AN
Orbis Medisch Centrum
Sittard-Geleen, Netherlands, 6162 BG
Tweestedenziekenhuis/Oncology
Tilburg, Netherlands, 5042AD
Portugal
Comissão de Ética para a Investigação Clínica
Lisboa, Portugal, 1749-004
Champalimaud Cancer Center/ Breast Unit
Lisboa, Portugal, 1400-038
Romania
Teo Health/ Oncology
Brasov, Romania, 500091
Spitalul Clinic CF nr.2 Bucuresti /Oncologie Medicala
Bucuresti, Romania, 011464
Spitalul Municipal Ploiesti/ Oncologie
Ploiesti, Romania, 100337
Spitalul Clinic Judetean de Urgenta Sibiu/ Oncologie
Sibiu, Romania, 550245
Spitalul Judetean de Urgente
Suceava, Romania, 720237
Spitalul Clinic Judetean Mures/ Clinica de Oncologie Medicala
Tg Mures, Romania, 0540142
Russian Federation
OGBUZ Belgorod Oncology Dispensary
Belgorod, Belgorodskaya oblast', Russian Federation, 308010
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
Ufa, Republic of Bashkortostan, Russian Federation, 450054
City Clinical Oncology Dispensary
Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary"
Pyatigorsk, Stavropol Territory,, Russian Federation, 357502
GBUZ Chelyabinsk regional clinical oncological dispensary
Chelyabinsk, Russian Federation, 454087
FGBU Russian Cancer Research Center n.a.NN Blokhin of Russian Academy of Medical Sciences
Moscow, Russian Federation, 115478
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
Saint Petersburg, Russian Federation, 198255
FGBVOU VPO "Military and Medical Academy n.a.
Saint-Petersburg, Russian Federation, 194044
Republican Clinical Oncology Dispensary/ Oncology
Ufa, Russian Federation, 450054
GOBUZ Regional clinical oncology dispensary
Velikiy Novgorod, Russian Federation, 173016
GBUZ Leningrad regional oncological dispensary
village Kuzmolovsky, Russian Federation, 188663
Taiwan
National Cheng Kung University Hospital [Surgical]
Taiman, Taiwan, 705
National Taiwan University Hospital/Oncology
Taipei, Taiwan, 100
Turkey
Ankara University Medical Faculty
Ankara, Turkey, 06100
Gazi University Medical Faculty Hospital
Besevler / Ankara, Turkey, 06500
Ege Universitesi Tip Fakultesi
Bornova/Izmir, Turkey, 35100
Hacettepe Universitesi Tip Fakultesi/Onkoloji Anabilim Dali
Sihhiye/Ankara, Turkey, 06100
Ukraine
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser/ viddilennia khimioterapii
Poltavs'ka Oblast', Poltava, Ukraine, 36011
ViOKOD
Vinnytsia, Vinnyts'ka Oblast', Ukraine, 21029
Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine, 49102
City Multiple-Discipline Clinical Hospital #4, Oncology Department
Dnipropetrovsk, Ukraine, 49102
Komunalna ustanova ##Chernivetskyi oblasnyi klinichnyi onkolohichnyi dyspanser##
m. Chernivtsi, Ukraine, 58013
Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolohichnyi dyspanser", viddilennia dennoho
m. Chernivtsi, Ukraine, 58013
Komunalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia № 4, Dnipropetrovskoi
m. Dnipropetrovsk, Ukraine, 49102
Komunalnyi zaklad "Dnipropetrovska miska bahatoprofilna klinichna likarnia № 4"
m. Dnipropetrovsk, Ukraine, 49102
Komunalnyi zaklad okhorony zdorovia "Kharkivskyi oblasnyi klinichnyi onkolohichnyi tsentr"
m. Kharkiv, Ukraine, 61070
Lvivskyi derzhavnyi onkolohichnyi rehionalnyi likuvalno-diahnostychnyi tsentr
m. Lviv, Ukraine, 79031
Komunalna ustanova "Odeska oblasna klinichna likarnia"
m. Odesa, Ukraine, 65025
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Poltavskoi oblasnoi rady
m. Poltava, Ukraine, 36011
Zakarpatskyi oblasnyi klinichnyi onkolohichnyi dyspanser
m. Uzhhorod, Ukraine, 88014
Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser
m. Vinnytsia, Ukraine, 21029
Odessa Regional Clinical Hospital/Mammalogical Center
Odessa, Ukraine, 65025
Transkarpathian Regional University Oncology Clinic/Chemotherapy
Uzhgorod, Ukraine, 88000
United Kingdom
Pfizer Investigational Site
Whitchurch, Cardiff, United Kingdom, CF14 2TL
Pfizer Investigational Site
London, United Kingdom, SW3 6JJ
Pfizer Investigational Site
Portsmouth, United Kingdom, PO6 3LY
Pfizer Investigational Site
Sheffield, United Kingdom, S10 2SJ
Sponsors and Collaborators
Pfizer
AstraZeneca
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01942135     History of Changes
Other Study ID Numbers: A5481023
Study First Received: September 10, 2013
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Palbociclib (PD-0332991)
Fulvestrant
Goserelin
Hormone receptor-+
HER2-negative
Prior Endocrine treatment
any menopausal status
PALOMA-3

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Estrogens

ClinicalTrials.gov processed this record on August 20, 2014