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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01942135
First received: September 10, 2013
Last updated: July 17, 2014
Last verified: July 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, The Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35233
Contact: Shameka Clark    205-934-0305    mekac@uab.edu   
UAB Hospital-Investigational Drug Service Recruiting
Birmingham, Alabama, United States, 35249
Contact: Shameka Clark    205-934-0305    mekac@uab.edu   
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Shameka Clark    205-934-0305    mekac@uab.edu   
Southern Cancer Center, PC Recruiting
Daphne, Alabama, United States, 36526
Contact: Christie Carter    251-607-5283    christie.carter@southerncancercenter.com   
Southern Cancer Center, PC Recruiting
Mobile, Alabama, United States, 36608
Contact: Christie Carter    251-607-5283    christie.carter@southerncancercenter.com   
Southern Cancer Center Recruiting
Mobile, Alabama, United States, 36608
Contact: Christie Carter    251-607-5283    christie.carter@southerncancercenter.com   
Southern Cancer Center, PC Recruiting
Mobile, Alabama, United States, 36607
Contact: Christie Carter    251-607-5283    christie.carter@southerncancercenter.com   
United States, Arizona
Arizona Center for Cancer Care Recruiting
Avondale, Arizona, United States, 85323
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
Ironwood Cancer and Research Centers, PC Recruiting
Chandler, Arizona, United States, 85224
Contact: Amy Purvis    480-855-2227    apurvis@ironwoodcrc.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Flagstaff, Arizona, United States, 86002
Contact: Nancy Precour         
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Gilbert, Arizona, United States, 85297
Contact: Amy Purvis    480-855-2227    apurvis@ironwoodcrc.com   
Arizona Center for Cancer Care Recruiting
Glendale, Arizona, United States, 85306
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
Palo Verde Hematology Oncology Recruiting
Glendale, Arizona, United States, 85304
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
Western Regional Medical Center, Inc. Recruiting
Goodyear, Arizona, United States, 85338
Contact: Brenda Noggy    713-704-7100    brenda.t.noggy@nth.tmc.edu   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Mesa, Arizona, United States, 85206
Contact: Amy Purvis    480-855-2227    apurvis@ironwoodcrc.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Mesa, Arizona, United States, 85202
Contact: Amy Purvis    480-855-2227    apurvis@ironwoodcrc.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Phoenix, Arizona, United States, 85028
Contact: Amy Purvis    480-855-2227    apurvis@ironwoodcrc.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Prescott Valley, Arizona, United States, 86314
Contact: Nancy Precour         
21st Century Oncology Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Sedona, Arizona, United States, 86336
Contact: Nancy Precour         
Northern Arizona Hematology & Oncology Associates Recruiting
Sedona, Arizona, United States, 86336
Contact: Nancy Precour         
Arizona Center for Cancer Care Recruiting
Surprise, Arizona, United States, 85374
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
The University of Arizona Cancer Center- North Campus Recruiting
Tucson, Arizona, United States, 85719
Contact: Yrma Burruel    520-694-9081    yburruel@uacc.arizona.edu   
The University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Yrma Burruel    520-694-9081    yburruel@uacc.arizona.edu   
United States, California
UCLA Hematology Oncology Recruiting
Alhambra, California, United States, 91801
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
Contact: Joy Moss    661-862-7158    jmoss@cbccusa.com   
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Kim Robinson    325-949-1646    kimrobinson@benchmarkresearch.net   
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center Recruiting
Fullerton, California, United States, 92835
Contact: Gayle Madden-Mathes    714-446-5900    gmadden@mednet.ucla.edu   
Global Research Management Recruiting
Glendale, California, United States, 91204
Contact: Genelou F Yumping    562-633-5101    lukrgyn@yahoo.com   
UCLA Hematology Oncology Recruiting
Irvine, California, United States, 92604
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UC San Diego Moores Cancer Center-Investigational Drug Services Recruiting
La Jolla, California, United States, 92037-0845
Contact: Larissa Low    619-543-2644    Llow@ucsd.edu   
UC San Diego Medical Center-La Jolla Recruiting
La Jolla, California, United States, 92037
Contact: Larissa Low    619-543-2644    Llow@ucsd.edu   
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92037
Contact: Larissa Low    619-543-2644    Llow@ucsd.edu   
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Larissa Low    619-543-2644    Llow@ucsd.edu   
Breastlink Medical Group, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: Deidre Carrillo         
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Joy Moss    661-862-7158    jmoss@cbccusa.com   
UCLA Hematology-Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Laura Murphy    203-452-6784    lmurphy@hopewcc.com   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Lee Walton    805-543-5577 ext 123    LWalton@ohmacc.com   
Administrative Management Only Recruiting
Los Angeles, California, United States, 90045
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Julio Doligosa    847-731-4106    irene.quimby@ctca-hope.com   
Administrative Management Only: Translational Research Management Recruiting
Los Angeles, California, United States, 90045
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Maria Mejia    805-346-3466    mmejia@ccsb.org   
Administrative Management Only Recruiting
Los Angeles, California, United States, 90045
Contact: Cherie Cox    541-269-8392    ccox@bayareahospital.org   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Brenda Noggy    713-704-7100    brenda.t.noggy@nth.tmc.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Gayle Madden-Mathes    714-446-5900    gmadden@mednet.ucla.edu   
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
Regulatory Management Only: TRIO-US Central Adminstration Recruiting
Los Angeles, California, United States, 90095
Contact: Gayle Madden-Mathes    714-446-5900    gmadden@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Drug shipment only: Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
Contact: Joy Moss    661-862-7158    jmoss@cbccusa.com   
USC/Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Agustin A Garcia Caballero Monge         
Westwood Bowyer Clinic Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Brenda Noggy    713-704-7100    brenda.t.noggy@nth.tmc.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Julio Doligosa    847-731-4106    irene.quimby@ctca-hope.com   
LAC & USC Medical Center Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Agustin A Garcia Caballero Monge         
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Maria Mejia    805-346-3466    mmejia@ccsb.org   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
Keck Hospital of USC Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Agustin A Garcia Caballero Monge         
CRU Administrative Office: UCLA Hematology Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Laura Murphy    203-452-6784    lmurphy@hopewcc.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
Contact: Lee Walton    805-543-5577 ext 123    LWalton@ohmacc.com   
Administrative Management Only: Translational Research Management Recruiting
Los Angeles, California, United States, 90045
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
North Country Oncology Recruiting
Oceanside, California, United States, 92056
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
North County Oncology Medical Recruiting
Oceanside, California, United States, 92056
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
Medical Oncology Care Associates (MOCA) Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter    714-835-1800    Nancy.Walter@stjoe.org   
Breastlink Medical Group, Inc. Recruiting
Orange, California, United States, 92868
Contact: Deidre Carrillo         
St. Joseph Hospital Pharmacy Department (Drug Shipment Only) Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter    714-835-1800    Nancy.Walter@stjoe.org   
St. Joseph's Hospital / The Center for Cancer Prevention and Treatment Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter    714-835-1800    Nancy.Walter@stjoe.org   
Hematology-Oncology Medical Group of Orange County (HOMG) Recruiting
Orange, California, United States, 92868
Contact: Nancy Walter    714-835-1800    Nancy.Walter@stjoe.org   
UCLA/Pasadena HealthCare Recruiting
Pasadena, California, United States, 91105
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA Hematology Oncology-Porter Ranch Recruiting
Porter Ranch, California, United States, 91326
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
Cancer Care Associates Medical Group Recruiting
Redondo Beach,, California, United States, 90281
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
UC San Diego Medical Center-Hillcrest Recruiting
San Diego, California, United States, 92103
Contact: Larissa Low    619-543-2644    Llow@ucsd.edu   
University of California, San Francisco: Helen Diller Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Hope S Rugo         
UCSF Medical Center-Mt. Zion/Pharmaceutical Services Recruiting
San Francisco, California, United States, 94115
Contact: Hope S Rugo         
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Contact: Lee Walton    805-543-5577 ext 123    LWalton@ohmacc.com   
Edward Alexson, MD, Inc. Recruiting
Santa Ana, California, United States, 92705
Contact: Nancy Walter    714-835-1800    Nancy.Walter@stjoe.org   
Central Coast Medical Oncology Corporation Recruiting
Santa Maria, California, United States, 93454
Contact: Maria Mejia    805-346-3466    mmejia@ccsb.org   
UCLA Hematology Oncology Santa Monica-Parkside Recruiting
Santa Monica, California, United States, 90404
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA Santa Monica Medical Center and Orthopaedic Hospital Recruiting
Santa Monica, California, United States, 90404
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
UCLA Hematology Oncology Santa Monica Recruiting
Santa Monica, California, United States, 90404
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
City of Hope Medical Group Recruiting
South Pasadena, California, United States, 91030
Contact: Kim Robinson    325-949-1646    kimrobinson@benchmarkresearch.net   
UCLA/Santa Clarita Valley Cancer Center Recruiting
Valencia, California, United States, 91105
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
Wellness Oncology & Hematology Recruiting
West Hills, California, United States, 91307
Contact: Marylen Roldan    818-346-1773    marylen@wellnessoncology.com   
UCLA Westlake Village Hermatology Oncology Recruiting
Westlake Village, California, United States, 91361
Contact: Katie Orefice    661-255-5350    korefice@mednet.ucla.edu   
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    720-848-0664    tiffany.colvin@uchsc.edu   
University of Colorado Hospital Anschutz Outpatient Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    720-848-0664    tiffany.colvin@uchsc.edu   
University of Colorado Cancer Center (Drug Shipment Only) Recruiting
Aurora, Colorado, United States, 80045
Contact: Tiffany Colvin    720-848-0664    tiffany.colvin@uchsc.edu   
United States, Florida
University of Miami Hospital and Clinics (UHMC) Sylvester at Deerfield Beach Recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Lori Kronish    561-883-7511    lkronish@aptiumoncology.com   
Holy Cross Hospital-Michael and Dianne Bienes Comprehensive Cancer Center Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Eileen Georgi    954-267-7700    Eileen.Georgi@holy-cross.com   
University of Florida Health Shands Hospitals Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Kaitlyn Voelz    352-265-0680    kvoelz1@ufl.edu   
University of Florida Health Shands Cancer Hospital Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Kaitlyn Voelz    352-265-0680    kvoelz1@ufl.edu   
Davis Cancer Pavilion and Shands Medical Plaza Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Kaitlyn Voelz    352-265-0680    kvoelz1@ufl.edu   
Breast Cancer Center at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
Memorial Cancer Institute East Recruiting
Hollywood, Florida, United States, 33021
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
TRIO -US Central Administration Recruiting
Los Angeles, Florida, United States, 90095
Contact: Georgina Hollenbach    321-843-8370    Georgina.Hollenbach@orlandohealth.com   
UCLA West Medical Pharmacy Recruiting
Los Angles, Florida, United States, 90095-7349
Contact: Georgina Hollenbach    321-843-8370    Georgina.Hollenbach@orlandohealth.com   
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Lori Kronish    561-883-7511    lkronish@aptiumoncology.com   
Sylvester Comprehensive Cancer Center/ University of Miami Hospital and Clinics (UHMC) Recruiting
Miami, Florida, United States, 33136
Contact: Lori Kronish    561-883-7511    lkronish@aptiumoncology.com   
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Ana Aleman    305-674-2625    Ana.Aleman@msmc.com   
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Ana Aleman    305-674-2625    Ana.Aleman@msmc.com   
MSMC CCOP, Research Pharmacy Recruiting
Miami Beach, Florida, United States, 33140
Contact: Ana Aleman    305-674-2625    Ana.Aleman@msmc.com   
Orlando Health, Inc Recruiting
Orlando, Florida, United States, 32806
Contact: Georgina Hollenbach    321-843-8370    Georgina.Hollenbach@orlandohealth.com   
Memorial Cancer Institute West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Cheryl Habaue    954-844-9178    chabaue@mhs.net   
University of Miami Hospital and Clinics (UHMC) Sylvester at Plantation Recruiting
Plantation, Florida, United States, 33324
Contact: Lori Kronish    561-883-7511    lkronish@aptiumoncology.com   
United States, Georgia
Ann Johnston Recruiting
Atlanta, Georgia, United States, 30318
Contact: Ann L Johnston    678-298-3241    ajohnston@phoc.com   
Northwest Georgia Oncology Centers, P.C. Recruiting
Austell, Georgia, United States, 30106
Contact: Stephanie Bates    770-281-5101    Sbates@ngoc.com   
Northwest Georgia Oncology Centers, PC Recruiting
Carrollton, Georgia, United States, 30117
Contact: Stephanie Bates    770-281-5101    Sbates@ngoc.com   
Northwest Georgia Oncology Centers, PC Recruiting
Cartersville, Georgia, United States, 30121
Contact: Stephanie Bates    770-281-5101    Sbates@ngoc.com   
Northwest Georgia Oncology Centers, PC Recruiting
Douglasville, Georgia, United States, 30134
Contact: Stephanie Bates    770-281-5101    Sbates@ngoc.com   
Piedmont Cancer Institute, PC Recruiting
Fayetteville, Georgia, United States, 30214
Contact: Ann L Johnston    678-298-3241    ajohnston@phoc.com   
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Contact: Stephanie Bates    770-281-5101    Sbates@ngoc.com   
United States, Illinois
Rush-Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Contact: Joseph T Meschi         
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Lauren Niklinski    312-563-2842    lauren_niklinski@rush.edu   
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Contact: Joseph T Meschi         
Cancer Treatment Centers of America at Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Julio Doligosa    847-731-4106    irene.quimby@ctca-hope.com   
United States, Kansas
University of Kansas Cancer Center (Research Office) Recruiting
OVerland Park, Kansas, United States, 66210
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
University of Kansas Cancer Center Recruiting
Overland Park, Kansas, United States, 66210
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Brunswick, Maine, United States, 04011
Contact: Betsy Chase    207-396-7634    chasee@mccm.org   
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Sanford, Maine, United States, 04073
Contact: Betsy Chase    207-396-7634    chasee@mccm.org   
Maine Center For Cancer Medicine and Blood Disorders Recruiting
Scarborough, Maine, United States, 04074
Contact: Betsy Chase    207-396-7634    chasee@mccm.org   
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Scarborough, Maine, United States, 04074
Contact: Betsy Chase    207-396-7634    chasee@mccm.org   
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Elizabeth Yakim    443-287-6351    eyakim1@jhmi.edu   
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station Recruiting
Lutherville, Maryland, United States, 21093
Contact: Elizabeth Yakim    443-287-6351    eyakim1@jhmi.edu   
United States, Michigan
University of Michigan Health System/Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Sheryl Morgan    734-647-5944    shermorg@med.umich.edu   
Cancer & Hematology Centers of Western Michigan, PC Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Karen Kuiper    616-977-4878    kkuiper@chcwm.com   
Cancer and Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Karen Kuiper    616-977-4878    kkuiper@chcwm.com   
Cancer & Hematology Centers of Western Michigan, PC Recruiting
Holland, Michigan, United States, 49424
Contact: Karen Kuiper    616-977-4878    kkuiper@chcwm.com   
United States, Minnesota
Fairview Southdale Oncology Clinic Recruiting
Edina, Minnesota, United States, 55435
Contact: Amy Horst    612-625-0761    hors0033@umn.edu   
Drug Shipment Address: University of Minnesota Medical Center, Fairview IDS Pharmacy Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amy Horst    612-625-0761    hors0033@umn.edu   
University of Minnesota Physicians, Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amy Horst    612-625-0761    hors0033@umn.edu   
University of Minnesota Medical Center, Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Amy Horst    612-625-0761    hors0033@umn.edu   
United States, Missouri
Mercy Clinic St. Louis Cancer and Breast Institute Recruiting
Ballwin, Missouri, United States, 63011
Contact: Samia Das       Samia.das@mercy.net   
University of Kansas Cancer Center Recruiting
Kansas City, Missouri, United States, 64154
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
Kansas City Cancer Center Recruiting
Kansas City, Missouri, United States, 64111
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
University of Kansas Cancer Center Recruiting
Kansas City, Missouri, United States, 64131
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
Washington University Infusion Center Pharmacy Not yet recruiting
St Louis, Missouri, United States, 63110
Contact: Shana Thomas    314-747-5209    SNTHOMAS@DOM.wustl.edu   
Mercy Hospital St. Louis Recruiting
St. Louis, Missouri, United States, 63141
Contact: Samia Das       Samia.das@mercy.net   
Mercy Clinic St. Louis Cancer and Breast Institute Recruiting
St. Louis, Missouri, United States, 63109
Contact: Samia Das       Samia.das@mercy.net   
Washington University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Shana Thomas    314-747-5209    SNTHOMAS@DOM.wustl.edu   
Mercy Hospital St.Louis-David C. Pratt Cancer Center Recruiting
St. Louis, Missouri, United States, 63141
Contact: Samia Das       Samia.das@mercy.net   
Barnes- Jewish Hospital Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Shana Thomas    314-747-5209    SNTHOMAS@DOM.wustl.edu   
Siteman Cancer Center- South County Not yet recruiting
St. Louis, Missouri, United States, 63129
Contact: Shana Thomas    314-747-5209    SNTHOMAS@DOM.wustl.edu   
Siteman Cancer Center- West County Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Shana Thomas    314-747-5209    SNTHOMAS@DOM.wustl.edu   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89052
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89074
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Comprehensive Cancer Centers of Nevada Research Department Recruiting
Henderson, Nevada, United States, 89052
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Crystal Gutierrez    702-952-3388    crystal.gutierrez@usoncology.com   
United States, New Jersey
Rtugers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Elayne Wesolowsky    732-235-5198    wesoloel@cinj.rutgers.edu   
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Elayne Wesolowsky    732-235-5198    wesoloel@cinj.rutgers.edu   
United States, New York
Mount Kisco Medical Group Recruiting
Brewster, New York, United States, 10509
Contact: Anh Phung    914-666-1366    aphung@nwhc.net   
ProHEALTH Care Associates, LLP Recruiting
Lake Success, New York, United States, 11042
Contact: Desiree Grogan    516-482-4790    desireegrogan@hotmail.com   
Northern Westchester Hospital Recruiting
Mount Kisco, New York, United States, 10549
Contact: Anh Phung    914-666-1366    aphung@nwhc.net.com   
Anh Phung Recruiting
Mount Kisco, New York, United States, 10549
Contact: Anh Phung    914-666-1366    aphung@nwhc.net   
United States, North Carolina
Hope Women's Cancer Centers Recruiting
Asheville, North Carolina, United States, 28806
Contact: Laura Murphy    203-452-6784    lmurphy@hopewcc.com   
Mission Hospital, Inc. Recruiting
Asheville, North Carolina, United States, 28806
Contact: Laura Murphy    203-452-6784    lmurphy@hopewcc.com   
United States, Ohio
Toledo Community Oncology Program Recruiting
Toledo, Ohio, United States, 43617
Contact: Joanne Lenkay    419-843-6147 ext 228    jlenkay@tcop.info   
Toledo Clinic Cancer Center - Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Joanne Lenkay    419-843-6147 ext 228    jlenkay@tcop.info   
The University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Joanne Lenkay    419-843-6147 ext 228    jlenkay@tcop.info   
United States, Oregon
North Bend Medical Center Inc. Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Cherie Cox    541-269-8392    ccox@bayareahospital.org   
Bay Area Hospital Recruiting
Coos Bay, Oregon, United States, 97420
Contact: Cherie Cox    541-269-8392    ccox@bayareahospital.org   
United States, Pennsylvania
UPMC Cancer Center, Monroeville Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Sandra Sheets    612-870-5512    sandra.sheets@mngastro.com   
Thomas Jefferson University, Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Monica McGuire       Monica.McGuire@jefferson.edu   
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Monica McGuire       Monica.McGuire@jefferson.edu   
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amy Marshall    215-662-2190    Amy.Marshall@uphs.upenn.edu   
Universsity of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sandra Sheets    612-870-5512    sandra.sheets@mngastro.com   
Magee Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sandra Sheets    612-870-5512    sandra.sheets@mngastro.com   
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sandra Sheets    612-870-5512    sandra.sheets@mngastro.com   
Guthrie Clinic, LTD Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Cynthia A Lynch         
United States, Tennessee
The Jones Clinic, PC Recruiting
Germantown, Tennessee, United States, 38138
Contact: Lori Lynch    901-685-5969 ext 0322    llynch@jonescancerclinic.com   
United States, Texas
Texas Oncology- Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Contact: Kristi J McIntyre         
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Billie J Marek         
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: William A Houck         
Investigational Products Center (IPC) (Durg Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Kristi J McIntyre         
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Investigational Products Center (IPC), (Druh Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Valerie Francis    913-894-7365    vfrancis1@nuvox.net   
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Brittany Boswell    903-535-4679    brittany.boswell@usoncology.com   
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Nancy Precour         
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Noel Swafford    703-208-3174    noel.swafford@usoncology.com   
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Kimberly Polley    757-466-8683    kim.polley@usoncology.com   
Memorial Hermann Hospital- TMC Not yet recruiting
Houston, Texas, United States, 77030
Contact: Katherine Klinger-Winton    713-486-6547    katherine.c.klingerwinton@uth.tmc.edu   
Memorial Hermann Hospital - TMC Not yet recruiting
Houston, Texas, United States, 77030
Contact: Katherine Klinger-Winton    713-486-6547    katherine.c.klingerwinton@uth.tmc.edu   
UT/Memorial Hermann Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Katherine Klinger-Winton    713-486-6547    katherine.c.klingerwinton@uth.tmc.edu   
Texas Oncology- Longview Cancer Center Recruiting
Longview, Texas, United States, 75601
Contact: Brittany Boswell    903-535-4679    brittany.boswell@usoncology.com   
Texas Oncology- McAllen South Second Street Recruiting
McAllen, Texas, United States, 78503
Contact: Billie J Marek         
South Texas Cancer Center Recruiting
McAllen, Texas, United States, 78503
Contact: Billie J Marek         
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78258
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78217
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78212
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Texas Oncology-Tyler Recruiting
Tyler, Texas, United States, 75702
Contact: Brittany Boswell    903-535-4679    brittany.boswell@usoncology.com   
Texas Oncology- Weslaco Recruiting
Weslaco, Texas, United States, 78596
Contact: Billie J Marek         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Bernadette J Bittner    801-587-4567    Bernadette.Bittner@hci.utah.edu   
Huntsman Cancer Hospital Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Bernadette J Bittner    801-587-4567    Bernadette.Bittner@hci.utah.edu   
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Arlington, Virginia, United States, 22205
Contact: Noel Swafford    703-208-3174    noel.swafford@usoncology.com   
Emily Couric Clinical Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Lisa Malyn    434-243-0425    lak7a@hscmail.mcc.virginia.edu   
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Lisa Malyn    434-243-0425    lak7a@hscmail.mcc.virginia.edu   
Medical Oncology & Hematology Associates of Northern Virginia, LTD Recruiting
Fairfax, Virginia, United States, 22031
Contact: Samiha Islam    703-207-0733    samihaislam@nvoncology.com   
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Noel Swafford    703-208-3174    noel.swafford@usoncology.com   
Virginia Cancer Specialists, PC Recruiting
Leesburg, Virginia, United States, 20176
Contact: Noel Swafford    703-208-3174    noel.swafford@usoncology.com   
Virginia Oncology Associates Recruiting
Newport News, Virginia, United States, 23606
Contact: Kimberly Polley    757-466-8683    kim.polley@usoncology.com   
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Kimberly Polley    757-466-8683    kim.polley@usoncology.com   
Medical Oncology & Hematology Associates of Northern Virginia Recruiting
Reston, Virginia, United States, 20190
Contact: Samiha Islam    703-207-0733    samihaislam@nvoncology.com   
Virginia Oncology Associates Recruiting
Virginia Beach, Virginia, United States, 23456
Contact: Kimberly Polley    757-466-8683    kim.polley@usoncology.com   
Shenandoah Oncology Recruiting
Winchester, Virginia, United States, 22601
Contact: William A Houck         
United States, Washington
Swedish Medical Center Investigational Drug Services Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Cara Wiseman    206-386-2301    cara.wiseman@swedish.org   
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98122
Contact: Cara Wiseman    206-386-2301    cara.wiseman@swedish.org   
Swedish Cancer Institute Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Cara Wiseman    206-386-2301    cara.wiseman@swedish.org   
United States, Wisconsin
Julie Hugg Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Julie Hugg    414-298-7250    jhugg@columbia-stmarys.org   
Columbia St. Mary's Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Julie Hugg    414-298-7250    jhugg@columbia-stmarys.org   
Australia, New South Wales
Bankstown - Lidcombe Hospital Not yet recruiting
Bankstown, New South Wales, Australia, 2200
Contact: Roseanne Wong    +61 2 9722 8621    shuet-oi.wong@sswahs.nsw.gov.au   
Calvary Mater Newcastle Not yet recruiting
Newcastle, New South Wales, Australia, 2298
Contact: Kim Adler    +61 2 40413282    Kim.Adler@calvarymater.org.au   
Australia, Queensland
Nambour General Hospital Not yet recruiting
Nambour, Queensland, Australia, 4560
Contact: Christine Cocks    +61 (07) 5470-6202    Christine.Cocks@health.qld.gov.au   
Icon Cancer Care Southport Recruiting
Southport, Queensland, Australia, 4215
Contact: Troy Wood    +61 7 5657 6452    TWood@iconcancercare.com.au   
Australia, South Australia
Flinders Medical Centre Not yet recruiting
Bedford Park, South Australia, Australia, 5042
Contact: Swan Monique    +61-882042702    Monique.swan@health.sa.gov.au   
Australia, Victoria
Peter MacCallum Cancer Centre Ethics Committee Recruiting
East Melbourne, Victoria, Australia, 8006
Contact: Claire Coulson    +61 3 9656 1111    Claire.coulson@petermac.org   
Western Health, The Western Hospital Recruiting
Footscray, Victoria, Australia, 3011
Contact: Angela Baugh    +61 3 8345 6736    AngelaM.Baugh@wh.org.au   
Western Health/Medical Oncology and Hematolog Recruiting
Footscray, Victoria, Australia, 3011
Contact: Angela Baugh    +61 3 8345 6736    AngelaM.Baugh@wh.org.au   
Frankston Hospital/Peninsula Oncology Centre Recruiting
Frankston, Victoria, Australia, 3199
Contact: Anne-Marie Lobo-Davids    +61-3-97718907    sasha.trantino@monash.edu   
Barwon Health - The Geelong Hospital Not yet recruiting
Geelong, Victoria, Australia, 3220
Contact: Lea-Anne Harrison    +61 3 5226 7858    leaanne.harrison@barwonhealth.org.au   
Australia, Western Australia
Royal Perth Hospital/Medical Oncology Not yet recruiting
Perth, Western Australia, Australia, 6000
Contact: Caroline L Stone    +61(0)892241317    caroline.stone@health.wa.gov.au   
Australia
Cabrini Brighton Not yet recruiting
Brighton, Australia, 3186
Contact: Barbara Scher    (03) 9508 3410    bscher@cabrini.com.au   
Monash Cancer Centre Recruiting
East Bentleigh, Australia, 3165
Contact: Kim Brewin       kim.brewin@monashhealth.org   
Cabrini Hospital Not yet recruiting
Malvern, Australia, 3144
Contact: Barbara Scher    (03) 9508 3410    bscher@cabrini.com.au   
Belgium
UZ Antwerpen/ Oncologie Not yet recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Ann Decoene    0113238213250    ann.decoene@uza.be   
Clinique St Pierre Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Isabelle Vanbellinghen    011113210437348    vanbellinghen@clinique-saint-pierre.be   
Grand Hôpital de Charleroi - Site Notre Dame / Oncologie - Hématologie Recruiting
Charleroi, Hainaut, Belgium, 6000
Contact: Janique Dewelle    +32 71 10 47 09    janique.dewelle@ghdc.be   
Centre Hospitalier Jolimont Recruiting
Haine St. Paul, Hainaut, Belgium, 7100
Contact: Thècle Fourneaux    +32 64 23 41 79    thecle.fourneaux@entitejolimontoise.be   
Chaussée de Saint-Amand 80 Recruiting
Tournai, Hainaut, Belgium, 7500
Contact: Olivia Ponchau    32 69 88 50 30    OLIVIA.PONCHAU@chwapi.be   
Queen's University - Kingston General Hospital Recruiting
Kingston, ON, Belgium, K7L 5P9
Contact: Francoise Henry    32 2 555 72 86    Francoise.Henry@erasme.ulb.ac.be   
Clinique Ste Elisabeth / Not yet recruiting
Roselare, West-Vlaanderen, Belgium, 8800
Contact: Els Verbruggen    +32 51 23 37 04    EVerbruggen@hhr.be   
Imelda Ziekenhuis / Oncology Recruiting
Antwerpen, Belgium, 2820
Contact: Wim L Wynendaele         
C.H.U. Brugmann, Hematologie Not yet recruiting
Brussels, Belgium, 1020
Contact: Mukiana Mahwoko    3224773315    mukiana.mahwoko@chu-brugmann.be   
Cliniques Universitaires Saint-Luc/Oncologie Médicale Recruiting
Bruxelles, Belgium, 1200
Contact: Nathalie Blondeel    32 2 764 42 14    nathalie.blondeel@uclouvain.be   
Jules Bordet Institute-Medical Oncology Clinic Not yet recruiting
Bruxelles, Belgium, 1000
Contact: Anna Kim Un Ok Mirjam Bergström    +32 2 541 72 45    annakim.bergstrom@bordet.be   
Universitair Ziekenhuis Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact: Joke De Roover    32-16-34-74-19    joke.deroover@uz.kuleuven.ac.be   
C.H. de l'Ardenne Recruiting
Libramont, Belgium, 6800
Contact: Oumhani Meftahi    +3261622683    oumhani.meftahi@cha.be   
CHU de Liège/ Oncologie Médicale Recruiting
Liège, Belgium, 4000
Contact: Maude Piron    +32 4 366 71 11 bip 4454    mpiron@chu.ulg.ac.be   
Clinique Ste Elisabeth / Oncologie Recruiting
Namur, Belgium, 5000
Contact: Caroline Yague    +32.81.72.05.47    data.ohr@cmsenamur.be   
AZ Nikolaas Not yet recruiting
Sint-Niklaas, Belgium, 9100
Contact: Christine Maes    3237602573    christine.maes@aznikolaas.be   
Sint Augustinusziekenhuis Wilrijk / Medical Oncology Not yet recruiting
Wilrijk, Belgium, 2610
Contact: Hilde Maes    +32 3 443 37 59    hilde.maes@gza.be   
Canada, British Columbia
Carol Winn Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Cherie Bates    250-862-8141    cherie@okanaganclinicaltrials.com   
B.C. Cancer Agency, Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Monica Fourt    604-930-4064    mfourt@bccancer.bc.ca   
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Kimberley Marsh-Gray    705-728-9090 x 43340    marshk@rvh.on.ca   
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Jackie Edwards    613-549-6666, ext: 6820    jackie.edwards@krcc.on.ca   
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Linda M Klich    905-576-8711 x3416    lklich@lakeridgehealth.on.ca   
Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1h 8L6
Contact: Natalie Andrew's Wright    +1-613-737-8899    nawright@toh.on.ca   
Niagara Health System - Walker Family Cancer Centre Recruiting
St. Catharines, Ontario, Canada, L2S 0A9
Contact: Julie Moscher    9056826451    Julie.Moscher@niagarahealth.on.ca   
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jeffrey Pham    416) 480-5000 ext. 1055    Jeff.Pham@sunnybrook.ca   
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Kjirsten Nyquist-Schultz    416-581-7892    Kjirsten.Nyquist-Schultz@uhn.ca   
Toronto East General Hospital Recruiting
Toronto, Ontario, Canada, M4C 3E7
Contact: Anoush Yaminifar    +14164696580    ayami@tegh.on.ca   
Sunnybrook Health Sciences Centre - Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jeffrey Pham    416) 480-5000 ext. 1055    Jeff.Pham@sunnybrook.ca   
Germany
Pfizer Investigational Site Recruiting
Kiel, SH, Germany, D-24105
Pfizer Investigational Site Not yet recruiting
Berlin, Germany, 10967
Pfizer Investigational Site Not yet recruiting
Kiel, Germany, 24103
Pfizer Investigational Site Recruiting
Kiel, Germany, 24105
Pfizer Investigational Site Not yet recruiting
Köln, Germany, 50931
Pfizer Investigational Site Recruiting
Leipzig, Germany, 04103
Pfizer Investigational Site Not yet recruiting
München, Germany, 80337
Ireland
Bon Secours Hospital Recruiting
Cork, Ireland
Contact: Conleth G Murphy         
Beaumont Hospital, Cancer Clinical Trials & Research Unit Not yet recruiting
Dublin, Ireland, Dublin 9
Contact: Derval Kehily    +353 (0)1 8092010    dervalkehily@beaumont.ie   
St James's Hospital Not yet recruiting
Dublin, Ireland, Dublin 8
Contact: Ingrid Kiernan    +353 1 4103754    ikiernan@stjames.ie   
Sligo General Hospital Not yet recruiting
Sligo, Ireland
Contact: Michael J Martin         
Italy
Pfizer Investigational Site Not yet recruiting
Bagno a Ripoli (FI), Firenze, Italy, 50012
Pfizer Investigational Site Recruiting
Bologna, Italy, 40138
Pfizer Investigational Site Recruiting
Catania, Italy, 95123
Pfizer Investigational Site Not yet recruiting
Meldola (FC), Italy, 47014
Pfizer Investigational Site Recruiting
Milano, Italy, 20132
Pfizer Investigational Site Recruiting
Milano, Italy, 20133
Pfizer Investigational Site Recruiting
Milano, Italy, 20141
Pfizer Investigational Site Not yet recruiting
Napoli, Italy, Via Mariano Semmola
Pfizer Investigational Site Not yet recruiting
Palermo, Italy, 90127
Pfizer Investigational Site Not yet recruiting
Roma, Italy, 00161
Pfizer Investigational Site Not yet recruiting
Roma, Italy, 00189
Pfizer Investigational Site Not yet recruiting
Roma, Italy, 00144
Pfizer Investigational Site Recruiting
Roma, Italy, 00168
Pfizer Investigational Site Recruiting
Terni, Italy, 05100
Japan
Pfizer Investigational Site Not yet recruiting
Kashiwa, Chiba, Japan
Pfizer Investigational Site Recruiting
Matsuyama-city, Ehime, Japan
Pfizer Investigational Site Recruiting
Kita-adachi-gun, Saitama, Japan
Pfizer Investigational Site Recruiting
Aichi, Japan
Pfizer Investigational Site Recruiting
Chiba, Japan
Pfizer Investigational Site Recruiting
Fukuoka, Japan
Pfizer Investigational Site Recruiting
Kagoshima, Japan
Pfizer Investigational Site Recruiting
Osaka, Japan
Korea, Republic of
Seoul National University Bundang Hospital, Hematology-oncology Recruiting
Seongnam, Gyunggido, Korea, Republic of, 463-707
Contact: Surim An    +82-31-787-8211    r1154@snubh.org   
Seoul National University Hospital Recruiting
Seoul, Republic of Korea, Korea, Republic of, 110-744
Contact: Myoungsun Choi    82 2072 1742 (107)    iamyou3@hanmail.net   
Samsung Medical Center [Hematology-Oncology] Recruiting
Gangnam-gu, Seoul, Korea, Republic of, 135-710
Contact: KyeoungHee Kim    +82 2 3410 0933    khfox.kim@samsung.com   
National Cancer Center, Center for Breast Cancer Recruiting
Goyang, Korea, Republic of, 410-769
Contact: Sukhee Lim    +82-31-920-0416    pposuki79@naver.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: KyeoungHee Kim    +82 2 3410 0933    khfox.kim@samsung.com   
Asan medical Center Not yet recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sun Young Kim    +82 42 600 9409    kwayy@naver.com   
Netherlands
Academisch Ziekenhuis Maastricht Not yet recruiting
Maastricht, Limburg, Netherlands, 6229 HX
Contact: Marianne v Kleef       marianne.vankleef@mumc.nl   
Leiden University Medical Center/ Clinical Oncology Recruiting
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Contact: Margret A.G. den Hollander    0031-71-5265450    M.A.G.den_Hollander@lumc.nl   
Haga Ziekenhuis, loc. Leyenburg / Internal Medicine Recruiting
Den Haag, Netherlands, 2545 CH
Contact: Lia Post    00-31-70-3217217    L.Post@ahz.nl   
Ikazia Ziekenhuis / Internal medicine Recruiting
Rotterdam, Netherlands, 3083 AN
Contact: Corry Leunis-de Ruiter    0031-10-2975217    c.leunis@ikazia.nl   
Orbis Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6162 BG
Contact: Mireille Diependaal-Hoekstra    0031-88-4597800    m.hoekstra@orbisconcern.nl   
Tweestedenziekenhuis/Oncology Recruiting
Tilburg, Netherlands, 5042AD
Contact: Mandy Smeulders    01131134655639    msmeulders@tsz.nl   
Portugal
Comissão de Ética para a Investigação Clínica Recruiting
Lisboa, Portugal, 1749-004
Contact: Maria J Figueiredo    00351 22 5084000 Ext 7649    mjfigueiredo@ipoporto.min-saude.pt   
Champalimaud Cancer Center/ Breast Unit Not yet recruiting
Lisboa, Portugal, 1400-038
Contact: Ana Parece    00351 965009618    ana.parece@fundacaochampalimaud.pt   
Romania
Teo Health/ Oncology Not yet recruiting
Brasov, Romania, 500091
Contact: Eugeniu Banu         
Spitalul Clinic CF nr.2 Bucuresti /Oncologie Medicala Recruiting
Bucuresti, Romania, 011464
Contact: Carmen Crihana         
Spitalul Municipal Ploiesti/ Oncologie Recruiting
Ploiesti, Romania, 100337
Contact: Alina C Turcu         
Spitalul Clinic Judetean de Urgenta Sibiu/ Oncologie Recruiting
Sibiu, Romania, 550245
Contact: Monica Patran         
Spitalul Judetean de Urgente Recruiting
Suceava, Romania, 720237
Contact: Doina Elena Ganea         
Spitalul Clinic Judetean Mures/ Clinica de Oncologie Medicala Recruiting
Tg Mures, Romania, 0540142
Contact: Cornelia Toganel         
Russian Federation
OGBUZ Belgorod Oncology Dispensary Not yet recruiting
Belgorod, Belgorodskaya oblast', Russian Federation, 308010
Contact: Ludmila I Kuzina         
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan Recruiting
Ufa, Republic of Bashkortostan, Russian Federation, 450054
Contact: Leysyan I Mirkhaydarova    +74953613917    lipatovoleg@bk.ru   
FGU Research Institute of Oncology named after N.N.Petrov o Not yet recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 190000
Contact: Vladimir M Moiseyenko         
City Clinical Oncology Dispensary Not yet recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 197022
Contact: Alexandra Chiritso    +79213108501    sasha_chirico@mail.ru   
GBUZ of Stavropol Territory "Pyatigorsk Oncology Dispensary" Recruiting
Pyatigorsk, Stavropol Territory,, Russian Federation, 357502
Contact: Irina Verbitskaya    +7 928 904 32 30    Verbickaja2010@yandex.ru   
GBUZ Chelyabinsk regional clinical oncological dispensary Not yet recruiting
Chelyabinsk, Russian Federation, 454087
Contact: Kristina A Azeva    +79507207288    nurse3@mail.ru   
FGBU Russian Cancer Research Center n.a.NN Blokhin of Russian Academy of Medical Sciences Recruiting
Moscow, Russian Federation, 115478
Contact: Sofia M Ivanina    +7 499 324 72 48    podd-elena@yandex.ru   
GBUZ of Nizhny Novgorod region Clinical diagnostic center Not yet recruiting
Nizhny Novgorod, Russian Federation, 603006
Contact: Elena Koroleva    +73833159921    keo@oblmed.nsk.ru   
Saint Petersburg GBUZ "City Clinical Oncology Dispensary" Not yet recruiting
Saint Petersburg, Russian Federation, 198255
Contact: Alexandra Chiritso    +79213108501    sasha_chirico@mail.ru   
FGBVOU VPO "Military and Medical Academy n.a. Not yet recruiting
Saint-Petersburg, Russian Federation, 194044
Contact: Tatiana V Brodskaya    7812-2923293    a_chuprina@rambler.ru   
Republican Clinical Oncology Dispensary/ Oncology Recruiting
Ufa, Russian Federation, 450054
Contact: Leysyan I Mirkhaydarova    +74953613917    lipatovoleg@bk.ru   
GOBUZ Regional clinical oncology dispensary Not yet recruiting
Velikiy Novgorod, Russian Federation, 173016
Contact: Vladimir Ivanchenko         
GBUZ Leningrad regional oncological dispensary Recruiting
village Kuzmolovsky, Russian Federation, 188663
Contact: Rustam Agishev    +79213678434    agiszew@gmail.com   
Taiwan
National Cheng Kung University Hospital [Surgical] Not yet recruiting
Taiman, Taiwan, 705
Contact: Tzu-En Huang    886-6-2353535 ext 5224    hung630423@yahoo.com.tw   
National Taiwan University Hospital/Oncology Recruiting
Taipei, Taiwan, 100
Contact: Yi-Ting Lin    886-2-28757496    r2923@hotmail.com   
Turkey
Gazi University Medical Faculty Hospital Not yet recruiting
Besevler / Ankara, Turkey, 06500
Contact: Ramazan Yildiz         
Hacettepe Universitesi Tip Fakultesi/Onkoloji Anabilim Dali Not yet recruiting
Sihhiye/Ankara, Turkey, 06100
Contact: Mustafa K Altundag         
Ukraine
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser/ viddilennia khimioterapii Not yet recruiting
Poltavs'ka Oblast', Poltava, Ukraine, 36011
Contact: Anatolii Chornobai         
ViOKOD Not yet recruiting
Vinnytsia, Vinnyts'ka Oblast', Ukraine, 21029
Contact: Petro Odarchenko         
Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy Recruiting
Dnipropetrovsk, Ukraine, 49102
Contact: Nataliya Kitsera       nkitsera@ukr.net   
City Multiple-Discipline Clinical Hospital #4, Oncology Department Recruiting
Dnipropetrovsk, Ukraine, 49102
Contact: Yevgeniya V Alikova    011380562585372    Ealikova2008@ukr.net   
Komunalna ustanova ##Chernivetskyi oblasnyi klinichnyi onkolohichnyi dyspanser## Not yet recruiting
m. Chernivtsi, Ukraine, 58013
Contact: Anatoliy Hontsa         
Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolohichnyi dyspanser", viddilennia dennoho Not yet recruiting
m. Chernivtsi, Ukraine, 58013
Contact: Anatoliy Hontsa         
Komunalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia № 4, Dnipropetrovskoi Recruiting
m. Dnipropetrovsk, Ukraine, 49102
Contact: Yevgeniya V Alikova    011380562585372    Ealikova2008@ukr.net   
Komunalnyi zaklad "Dnipropetrovska miska bahatoprofilna klinichna likarnia № 4" Recruiting
m. Dnipropetrovsk, Ukraine, 49102
Contact: Yevgeniya V Alikova    011380562585372    Ealikova2008@ukr.net   
Komunalnyi zaklad okhorony zdorovia "Kharkivskyi oblasnyi klinichnyi onkolohichnyi tsentr" Recruiting
m. Kharkiv, Ukraine, 61070
Contact: Yuriy Vinnyk         
Lvivskyi derzhavnyi onkolohichnyi rehionalnyi likuvalno-diahnostychnyi tsentr Recruiting
m. Lviv, Ukraine, 79031
Contact: Nataliya Kitsera       nkitsera@ukr.net   
Komunalna ustanova "Odeska oblasna klinichna likarnia" Not yet recruiting
m. Odesa, Ukraine, 65025
Contact: Oleksandr Berzoy         
Poltavskyi oblasnyi klinichnyi onkolohichnyi dyspanser Poltavskoi oblasnoi rady Not yet recruiting
m. Poltava, Ukraine, 36011
Contact: Anatolii Chornobai         
Zakarpatskyi oblasnyi klinichnyi onkolohichnyi dyspanser Not yet recruiting
m. Uzhhorod, Ukraine, 88014
Contact: Anna Sochka    +380506733998    sochka_anna@inbox.ru   
Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser Not yet recruiting
m. Vinnytsia, Ukraine, 21029
Contact: Petro Odarchenko         
Odessa Regional Clinical Hospital/Mammalogical Center Not yet recruiting
Odessa, Ukraine, 65025
Contact: Oleksandr Berzoy         
Transkarpathian Regional University Oncology Clinic/Chemotherapy Not yet recruiting
Uzhgorod, Ukraine, 88000
Contact: Anna Sochka    +380506733998    sochka_anna@inbox.ru   
United Kingdom
Pfizer Investigational Site Not yet recruiting
Whitchurch, Cardiff, United Kingdom, CF14 2TL
Pfizer Investigational Site Recruiting
London, United Kingdom, SW3 6JJ
Pfizer Investigational Site Not yet recruiting
Portsmouth, United Kingdom, PO6 3LY
Pfizer Investigational Site Not yet recruiting
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: July 17, 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
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Estrogens

ClinicalTrials.gov processed this record on July 20, 2014