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.
Verified April 2014 by Pfizer
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01942135
First received: September 10, 2013
Last updated: April 10, 2014
Last verified: April 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
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
Southern Cancer Center, PC Recruiting
Daphne, Alabama, United States, 36526
Contact: Kristi Weir    251-607-5284    Kristi.Weir@southerncancercenter.com   
Southern Cancer Center, PC Recruiting
Mobile, Alabama, United States, 36607
Contact: Kristi Weir    251-607-5284    Kristi.Weir@southerncancercenter.com   
Southern Cancer Center Recruiting
Mobile, Alabama, United States, 36608
Contact: Kristi Weir    251-607-5284    Kristi.Weir@southerncancercenter.com   
Southern Cancer Center, PC Recruiting
Mobile, Alabama, United States, 36608
Contact: Kristi Weir    251-607-5284    Kristi.Weir@southerncancercenter.com   
United States, Arizona
Arizona Center for Cancer Care Not yet 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: Bobbi-Jo Campbell    480-855-2227    bcampbell@ironwoodcrc.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Flagstaff, Arizona, United States, 86002
Contact: Karen Freriks    928-204-4041    karen.freriks@usoncology.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Gilbert, Arizona, United States, 85297
Contact: Bobbi-Jo Campbell    480-855-2227    bcampbell@ironwoodcrc.com   
Palo Verde Hematology Oncology Recruiting
Glendale, Arizona, United States, 85304
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
Arizona Center for Cancer Care Not yet recruiting
Glendale, Arizona, United States, 85306
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
Western Regional Medical Center, Inc. Recruiting
Goodyear, Arizona, United States, 85338
Contact: Marci Pierog    623-207-3500    marci.pierog@ctca-hope.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Mesa, Arizona, United States, 85206
Contact: Bobbi-Jo Campbell    480-855-2227    bcampbell@ironwoodcrc.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Mesa, Arizona, United States, 85202
Contact: Bobbi-Jo Campbell    480-855-2227    bcampbell@ironwoodcrc.com   
Ironwood Physicians, PC d/b/a Ironwood Cancer & Research Centers, PC Recruiting
Phoenix, Arizona, United States, 85028
Contact: Bobbi-Jo Campbell    480-855-2227    bcampbell@ironwoodcrc.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Prescott Valley, Arizona, United States, 86314
Contact: Karen Freriks    928-204-4041    karen.freriks@usoncology.com   
21st Century Oncology Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Mary High    480-945-6896    mhigh@rtsx.com   
Northern Arizona Hematology & Oncology Associates Recruiting
Sedona, Arizona, United States, 86336
Contact: Karen Freriks    928-204-4041    karen.freriks@usoncology.com   
Arizona Oncology Associates, PC- NAHOA Recruiting
Sedona, Arizona, United States, 86336
Contact: Karen Freriks    928-204-4041    karen.freriks@usoncology.com   
Arizona Center for Cancer Care Not yet recruiting
Surprise, Arizona, United States, 85374
Contact: Victoria S Noboa    602-938-2848    vnoboa@arizonaccc.com   
United States, California
UCLA Hematology Oncology Recruiting
Alhambra, California, United States, 91801
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
City of Hope Not yet recruiting
Duarte, California, United States, 91010
Contact: Kim Robinson    626-256-4673 ext 64546    kimrobinson@coh.org   
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: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Breastlink Medical Group, Inc. Recruiting
Long Beach, California, United States, 90806
Contact: Andrea Provost    562-945-7626    RHARRISCDT@AOL.COM   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Alison Fernandez    805-739-3724    alison.fernandez@DignityHealth.org   
CRU Administrative Office: UCLA Hematology Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Administrative Management Only: Translational Research Management Not yet recruiting
Los Angeles, California, United States, 90045
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Marci Pierog    623-207-3500    marci.pierog@ctca-hope.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Free    805-543-5577    jfree@ohmacc.com   
Administrative Management Only Not yet 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: Deneise Francis    954-265-2796    dfrancis@mhs.net   
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   
UCLA Hematology-Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
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, 90095-7349
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Gayle Madden-Mathes    714-446-5900    gmadden@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Jill Smith    847-872-4701    jill.smith@ctca-hope.com   
Westwood Bowyer Clinic Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Free    805-543-5577    jfree@ohmacc.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Marci Pierog    623-207-3500    marci.pierog@ctca-hope.com   
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
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: Alisha Meade    828-418-1354    ameade@hopewcc.com   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Alison Fernandez    805-739-3724    alison.fernandez@DignityHealth.org   
TRIO- US Central Administration Recruiting
Los Angeles, California, United States, 90095
Contact: Alisha Meade    828-418-1354    ameade@hopewcc.com   
UCLA West Medical Pharmacy Recruiting
Los Angeles, California, United States, 90095-7349
Contact: Jill Smith    847-872-4701    jill.smith@ctca-hope.com   
Drug shipment only: Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
North Country Oncology Not yet recruiting
Oceanside, California, United States, 92056
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
North County Oncology Medical Not yet recruiting
Oceanside, California, United States, 92056
Contact: Marina Marinine    760-758-5770 ext 126    NCOMC.Clinical.Research@gmail.com   
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   
Breastlink Medical Group, Inc. Recruiting
Orange, California, United States, 92868
Contact: Andrea Provost    562-945-7626    RHARRISCDT@AOL.COM   
Medical Oncology Care Associates (MOCA) 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: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
UCLA Hematology Oncology-Porter Ranch Recruiting
Porter Ranch, California, United States, 91326
Contact: Monica Rocha    310-582-6324    mprocha@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   
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Contact: Jessica Free    805-543-5577    jfree@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: Alison Fernandez    805-739-3724    alison.fernandez@DignityHealth.org   
UCLA Hematology Oncology Santa Monica-Parkside Recruiting
Santa Monica, California, United States, 90404
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
UCLA Santa Monica Medical Center and Orthopaedic Hospital Recruiting
Santa Monica, California, United States, 90404
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
UCLA Hematology Oncology Santa Monica Recruiting
Santa Monica, California, United States, 90404
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
City of Hope Medical Group Not yet recruiting
South Pasadena, California, United States, 91030
Contact: Kim Robinson    626-256-4673 ext 64546    kimrobinson@coh.org   
UCLA/Santa Clarita Valley Cancer Center Recruiting
Valencia, California, United States, 91355
Contact: Monica Rocha    310-582-6324    mprocha@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: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
United States, Colorado
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   
University of Colorado Cancer Center 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 Not yet recruiting
Deerfield Beach, Florida, United States, 33442
Contact: Donna Mitchell       d.mitchell6@med.miami.edu   
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: Alison M Ivey    352-265-0680 ext 88411    aivey@ufl.edu   
Davis Cancer Pavilion and Shands Medical Plaza Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Alison M Ivey    352-265-0680 ext 88411    aivey@ufl.edu   
University of Florida Health Shands Cancer Hospital Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Alison M Ivey    352-265-0680 ext 88411    aivey@ufl.edu   
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
Memorial Cancer Institute East Recruiting
Hollywood, Florida, United States, 33021
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
Breast Cancer Center at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
Sylvester Comprehensive Cancer Center/ University of Miami Hospital and Clinics (UHMC) Not yet recruiting
Miami, Florida, United States, 33136
Contact: Donna Mitchell       d.mitchell6@med.miami.edu   
Memorial Cancer Institute West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
Memorial Hospital West Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Deneise Francis    954-265-2796    dfrancis@mhs.net   
University of Miami Hospital and Clinics (UHMC) Sylvester at Plantation Not yet recruiting
Plantation, Florida, United States, 33324
Contact: Donna Mitchell       d.mitchell6@med.miami.edu   
United States, Georgia
Piedmont Cancer Institute, PC Recruiting
Atlanta, Georgia, United States, 30318
Contact: Ann Johnston    678-298-3241    ajohnston@phoc.com   
Piedmont Cancer Institute, PC Recruiting
Fayetteville, Georgia, United States, 30214
Contact: Ann Johnston    678-298-3241    ajohnston@phoc.com   
United States, Illinois
Rush-Copley Medical Center Recruiting
Aurora, Illinois, United States, 60504
Rush-Copley Healthcare Center Recruiting
Yorkville, Illinois, United States, 60560
Cancer Treatment Centers of America at Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Jill Smith    847-872-4701    jill.smith@ctca-hope.com   
United States, Maine
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Biddeford, Maine, United States, 04005
Contact: Merideth Harriman    207-885-7600    harrim@mccm.org   
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Brunswick, Maine, United States, 04011
Contact: Merideth Harriman    207-885-7600    harrim@mccm.org   
Maine Center for Cancer Medicine & Blood Disorders Recruiting
Sanford, Maine, United States, 04073
Contact: Merideth Harriman    207-885-7600    harrim@mccm.org   
Maine Center For Cancer Medicine and Blood Disorders Recruiting
Scarborough, Maine, United States, 04074
Contact: Merideth Harriman    207-885-7600    harrim@mccm.org   
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Andrea Beaver    443-614-6138    abeaver2@jhmi.edu   
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins Recruiting
Lutherville, Maryland, United States, 21093
Contact: Andrea Beaver    443-614-6138    abeaver2@jhmi.edu   
United States, Michigan
University of Michigan Health System/Comprehensive Cancer Center Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Cancer and Hematology Centers of Western Michigan Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Cancer & Hematology Centers of Western Michigan, PC Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Cancer & Hematology Centers of Western Michigan, PC Not yet recruiting
Holland, Michigan, United States, 49424
United States, Missouri
Mercy Clinic St. Louis Cancer and Breast Institute Not yet recruiting
Ballwin, Missouri, United States, 63011
Contact: Terri Edwards    314-251-7057    terri.edwards@mercy.net   
Mercy Hospital St.Louis-David C. Pratt Cancer Center Not yet recruiting
St. Louis, Missouri, United States, 63141
Contact: Terri Edwards    314-251-7057    terri.edwards@mercy.net   
Mercy Hospital St. Louis Not yet recruiting
St. Louis, Missouri, United States, 63141
Contact: Terri Edwards    314-251-7057    terri.edwards@mercy.net   
Mercy Clinic St. Louis Cancer and Breast Institute Not yet recruiting
St. Louis, Missouri, United States, 63109
Contact: Terri Edwards    314-251-7057    terri.edwards@mercy.net   
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89074
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89052
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Comprehensive Cancer Centers of Nevada Research Department Recruiting
Henderson, Nevada, United States, 89052
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Donna Katz    702-952-3444    DonnaKatz@mednet.ucla.edu   
United States, New Jersey
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Yadira E Spring    732-235-8591    springya@cinj.rutgers.edu   
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Yadira E Spring    732-235-8591    springya@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    516-622-6151    dgrogan@ProHealthcare.com   
Mount Kisco Medical Group Recruiting
Mount Kisco, New York, United States, 10549
Contact: Anh Phung    914-666-1366    aphung@nwhc.net   
Northern Westchester Hospital Recruiting
Mt 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: Alisha Meade    828-418-1354    ameade@hopewcc.com   
Mission Hospital, Inc. Recruiting
Asheville, North Carolina, United States, 28806
Contact: Alisha Meade    828-418-1354    ameade@hopewcc.com   
United States, Ohio
Toledo Community Oncology Program Recruiting
Toledo, Ohio, United States, 43617
The University of Toledo Medical Center Recruiting
Toledo, Ohio, United States, 43614
Toledo Clinic Cancer Center - Toledo Recruiting
Toledo, Ohio, United States, 43623
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
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Natalie Schultz    215-503-3039    Natalie.Schultz@jefferson.edu   
Thomas Jefferson University, Kimmel Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Natalie Schultz    215-503-3039    Natalie.Schultz@jefferson.edu   
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Janelle Robinson    215-662-7398    Janelle.Robinson@uphs.upenn.edu   
Guthrie Clinic, LTD Recruiting
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
The Jones Clinic, PC Recruiting
Germantown, Tennessee, United States, 38138
Contact: Lori Lynch       llynch@jonescancerclinic.com   
United States, Texas
Texas Oncology- Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Investigational Products Center (IPC) (Drug Shipment Only) Not yet recruiting
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (Durg Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Karen Freriks    928-204-4041    karen.freriks@usoncology.com   
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Investigational Products Center (IPC) (Drug Shipment Only) Not yet recruiting
Fort Worth, Texas, United States, 76177
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Investigational Products Center (IPC) (Drug Shipment Only) Not yet recruiting
Fort Worth, Texas, United States, 76177
Contact: Sonja Crandon       Sonja.crandon@usoncology.com   
Investigational Products Center (IPC) (Drug Shipment Only) Recruiting
Fort Worth, Texas, United States, 76177
Contact: Christy Cross    903-579-9878    christy.cross@usoncology.com   
Memorial Hermann Hospital- TMC Not yet recruiting
Houston, Texas, United States, 77030
Contact: Susan Cooper    832-325-6533    Susan.Cooper@uth.tmc.edu   
Memorial Hermann Hospital - TMC Not yet recruiting
Houston, Texas, United States, 77030
Contact: Susan Cooper    832-325-6533    Susan.Cooper@uth.tmc.edu   
UT/Memorial Hermann Cancer Center Not yet recruiting
Huston, Texas, United States, 77030
Contact: Susan Cooper    832-325-6533    Susan.Cooper@uth.tmc.edu   
Texas Oncology- Longview Cancer Center Recruiting
Longview, Texas, United States, 75601
Contact: Christy Cross    903-579-9878    christy.cross@usoncology.com   
Texas Oncology- McAllen South Second Street Recruiting
McAllen, Texas, United States, 78503
South Texas Cancer Center Recruiting
McAllen, Texas, United States, 78503
Cancer Care Centers of South Texas Not yet recruiting
San Antonio, Texas, United States, 78258
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Cancer Care Centers of South Texas Not yet recruiting
San Antonio, Texas, United States, 78217
Contact: Reaber Neal-Bryant    210-705-5744    rbryant@dgdresearch.com   
Cancer Care Centers of South Texas Not yet 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: Christy Cross    903-579-9878    christy.cross@usoncology.com   
Texas Oncology- Weslaco Recruiting
Weslaco, Texas, United States, 78596
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Lori Maness    801-587-4567    lori.maness@hci.utah.edu   
United States, Virginia
Virginia Cancer Specialists, PC Not yet recruiting
Arlington, Virginia, United States, 22205
Contact: Sonja Crandon       Sonja.crandon@usoncology.com   
Medical Oncology & Hematology Associates of Northern Virginia, LTD Recruiting
Fairfax, Virginia, United States, 22031
Contact: Clara K Tran    703-207-0733    clarat@nvoncology.com   
Virginia Cancer Specialists, PC Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Sonja Crandon       Sonja.crandon@usoncology.com   
Virginia Cancer Specialists, PC Not yet recruiting
Leesburg, Virginia, United States, 20176
Contact: Sonja Crandon       Sonja.crandon@usoncology.com   
Virginia Oncology Associates Not yet recruiting
Newport News, Virginia, United States, 23606
Virginia Oncology Associates Not yet recruiting
Norfolk, Virginia, United States, 23502
Medical Oncology & Hematology Associates of Northern Virginia Recruiting
Reston, Virginia, United States, 20190
Contact: Clara K Tran    703-207-0733    clarat@nvoncology.com   
Virginia Oncology Associates Not yet recruiting
Virginia Beach, Virginia, United States, 23456
Shenandoah Oncology, P.C. Recruiting
Winchester, Virginia, United States, 22601
United States, Wisconsin
Columbia St. Mary閒s Recruiting
Mequon, Wisconsin, United States, 53097
Contact: Julie Hugg    414-298-7250    jhugg@columbia-stmarys.org   
Columbia Saint Mary's Recruiting
Milwaukee, Wisconsin, United States, 53211
Contact: Julie Hugg    414-298-7250    jhugg@columbia-stmarys.org   
Australia, Victoria
Western Health/Medical Oncology and Hematolog Not yet recruiting
Footscray, Victoria, Australia, 3011
Contact: Shannon Uren    +613 9 656 1772    Shannon.Uren@petermac.org   
Belgium
Clinique St Pierre Recruiting
Ottignies, Brabant Wallon, Belgium, 1340
Contact: Martine Gerard    011113210437194    ma.gerard@clinique-saint-pierre.be   
Grand H�pital de Charleroi - Site Notre Dame / Oncologie - H�matologie 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: Th?e Fourneaux    +32 64 23 41 79    thecle.fourneaux@entitejolimontoise.be   
Chauss�e de Saint-Amand 80 Not yet recruiting
Tournai, Hainaut, Belgium, 7500
Contact: Olivia Ponchau    32 69 88 50 30    OLIVIA.PONCHAU@chwapi.be   
Imelda Ziekenhuis / Oncology Not yet recruiting
Antwerpen, Belgium, 2820
Contact: Ann Pauwels    0113215504868    sec.oncologie@imelda.be   
Cliniques Universitaires Saint-Luc/Oncologie Mdicale Not yet recruiting
Bruxelles, Belgium, 1200
Contact: Nathalie Blondeel    32 2 764 42 14    nathalie.blondeel@uclouvain.be   
Universitair Ziekenhuis Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact: Joris Caers    +32 10 8171-42    joris.caers@parexel.com   
C.H. de l'Ardenne Recruiting
Libramont, Belgium, 6800
Contact: C?ne Louis    +3261622683    Celine.Louis@cha.be   
CHU de Liege/ Oncologie Medicale Recruiting
Liege, Belgium, 4000
Contact: Maude Piron    0113243668250    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   
Canada, Ontario
Royal Victoria Regional Health Centre Recruiting
Barrie, Ontario, Canada, L4M 6M2
Contact: Michelle Harris    (214) 394-8225    Michelle.Harris2@USONCOLOGY.COM   
Cancer Centre of Southeastern Ontario at Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Stephanie Willing    613-549-6666 x: 6736    willings@kgh.kari.net   
Queen's University - Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Francoise Henry    32 2 555 72 86    Francoise.Henry@erasme.ulb.ac.be   
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   
The Ottawa Hospital Cancer Centre (General Campus) Not yet recruiting
Ottawa, Ontario, Canada, K1H-8L6
Contact: Carol Stober    +1-613-737-8899    cstober@toh.on.ca   
Sunnybrook Health Sciences Centre - Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto East General Hospital Not yet recruiting
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Niagara Health System Walker Family Cancer Centre Recruiting
Toronto, Ontario, Canada, L2S 0A9
Contact: Linda Illes    (905) 684-7271 Ext. 43801    linda.illes@niagarahealth.on.ca   
Netherlands
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 Rosier    01131702107261    l.rosier@hagaziekenhuis.nl   
Ikazia Ziekenhuis / Internal medicine Not yet recruiting
Rotterdam, Netherlands, 3083 AN
Contact: Amanda Deflers    0031-10-2975145    amandaapotheek@gmail.com   
Orbis Medisch Centrum Recruiting
Sittard-Geleen, Netherlands, 6162 BG
Contact: Rob Janknegt    0031-88-4597709    r.janknegt@orbisconcern.nl   
Tweestedenziekenhuis/Oncology Recruiting
Tilburg, Netherlands, 5042AD
Contact: Emile Maassen    01131134655639    emaassen@tsz.nl   
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: April 10, 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 April 16, 2014