Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01942135
First received: September 10, 2013
Last updated: July 13, 2016
Last verified: July 2016
  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 (Registered)). 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 (PFS) as Assessed by the Investigator [ Time Frame: From randomization date to date of first documentation of progression or death (assessed up to 12 months) ] [ Designated as safety issue: No ]
    PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.


Secondary Outcome Measures:
  • Overall Survival (OS) - Number of Participants Who Died [ Time Frame: From randomization until death (up to approximately 36 months) ] [ Designated as safety issue: No ]
    OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) - randomization date + 1]/30.4. No inferential statistical analysis were done because of the immaturity of the OS data.

  • Objective Response (OR) [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ] [ Designated as safety issue: No ]
    OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.

  • Duration of Response (DR) [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ] [ Designated as safety issue: No ]
    DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.

  • Clinical Benefit Response (CBR) [ Time Frame: From randomization until end of treatment (assessed up to 12 months) ] [ Designated as safety issue: No ]
    CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.

  • Survival Probabilities at Months 12, 24 and 36 [ Time Frame: From randomization until death (assessed up to 36 months) ] [ Designated as safety issue: No ]
    One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.

  • Observed Plasma Trough Concentration (Ctrough) for Palbociclib [ Time Frame: Cycle 1/Day 15 and Cycle 2/Day 15 ] [ Designated as safety issue: No ]
    Ctrough for palbociclib (if applicable). The method of dispersion applied here is "percent coefficient of variation" (%CV).

  • Ctrough for Fulvestrant [ Time Frame: Cycles 2/Day 1 and Cycle 3/Day 1 ] [ Designated as safety issue: No ]
    Ctrough for Fulvestrant (if applicable). The method of dispersion applied here is "percent coefficient of variation" (%CV).

  • Ctrough for Goserelin [ Time Frame: Cycles 2/ Day 1 and Cycle 3/ Day 1 ] [ Designated as safety issue: No ]
    Cmin for goserelin (if applicable). The method of dispersion applied here is "percent coefficient of variation" (%CV).

  • Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.

  • Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.

  • Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.

  • Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.

  • Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

  • Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale [ Time Frame: From Cycle 1 to 14, as of 05 December 2014. ] [ Designated as safety issue: No ]
    The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

  • Time to Deterioration (TTD) [ Time Frame: Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment ] [ Designated as safety issue: No ]
    A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities) [ Time Frame: From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months ] [ Designated as safety issue: No ]
    An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.


Enrollment: 521
Study Start Date: September 2013
Estimated Study Completion Date: January 2017
Primary Completion Date: December 2014 (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   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PI3K-mTOR pathway
  • Patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic CNS metastases
  • Major surgery or any anti-cancer therapy within 2 weeks of randomization
  • Prior stem cell or bone marrow transplantation
  • Use of potent CYP3A4 inhibitors or inducers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942135

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
UAB Hospital-Investigational Drug Service
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
Southern Cancer Center, PC
Mobile, Alabama, United States, 36607
Southern Cancer Center, PC
Mobile, Alabama, United States, 36608
Southern Cancer Center,PC
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona Center for Cancer Care
Avondale, Arizona, United States, 85323
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Arizona Oncology Associates, PC- NAHOA
Flagstaff, Arizona, United States, 86001
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Gilbert, Arizona, United States, 85297
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
Arizona Center for Cancer Care
Glendale, Arizona, United States, 85306
Western Regional Medical Center, Inc.
Goodyear, Arizona, United States, 85338
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Mesa, Arizona, United States, 85202
Ironwood Physicians P.C dba Ironwood Cancer & Research Centers
Mesa, Arizona, United States, 85206
Arizona Oncology Associates, PC- NAHOA
Prescott Valley, Arizona, United States, 86314
Arizona Oncology Associates, PC- NAHOA
Sedona, Arizona, United States, 86336
Arizona Center for Cancer Care
Surprise, Arizona, United States, 85374
The University of Arizona Cancer Center- North Campus
Tucson, Arizona, United States, 85719
The University of Arizona Cancer Center (Administrative Location)
Tucson, Arizona, United States, 85724
United States, California
UCLA Hematology Oncology - Alhambra
Alhambra, California, United States, 91801
CBCC Global Research Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Administrative Management Only: Translational Research Management
Culver City, California, United States, 90232
Administrative Management Only
Culver City, California, United States, 90232
Translational Research Management
Culver City, California, United States, 90232
City of Hope
Duarte, California, United States, 91010
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Global Research Management
Glendale, California, United States, 91204
UCLA Hematology Oncology - Irvine
Irvine, California, United States, 92604
UC San Diego Moores Cancer Center - Investigational Drug Services
La Jolla, California, United States, 92037-0845
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
UC San Diego Medical Center-La Jolla
La Jolla, California, United States, 92307
Drug Management Only: TRIO-US Pharmacy UCLA Med Plaza - Level 1 Attn: Steven L. Wong, Pharm. D.
Los Angelas, California, United States, 90095-7349
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC & USC Medical Center
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
TRIO-US Pharmacy, UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-1772
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
Los Angeles, California, United States, 90095-7349
Drug Management only: UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-7349
CRU Administrative Office: UCLA Hematology Oncology
Los Angeles, California, United States, 90095
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D
Los Angeles, California, United States, 90095
Drug Management only: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D
Los Angeles, California, United States, 90095
Drug shipment only: Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Regulatory Management only-TRIO -US Central Administration
Los Angeles, California, United States, 90095
Regulatory Management only: TRIO- US Central Administration
Los Angeles, California, United States, 90095
Regulatory Management only: TRIO-US Central Administration
Los Angeles, California, United States, 90095
Regulatory Management Only: TRIO-US Central Adminstration
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
TRIO- US Central Administration
Los Angeles, California, United States, 90095
UCLA Hematology Oncology
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic
Los Angeles, California, United States, 90095
Drug management only: UCLA West Medical Pharmacy, attn:
Los Angles, California, United States, 90095-7349
Breastlink Medical Group, Inc.
Orange, California, United States, 92868
Hematology Oncology Medical Group of Orange County, Inc. (HOMG)
Orange, California, United States, 92868
St. Joseph Hospital Pharmacy Department (Drug Shipment Only)
Orange, California, United States, 92868
The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
Orange, California, United States, 92868
UCLA Hematology/Oncology - Pasadena
Pasadena, California, United States, 91105
UCLA Hematology Oncology - Porter Ranch
Porter Ranch, California, United States, 91326
Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates Medical
Redondo Beach, California, United States, 90277
UC San Diego Medical Center-Hillcrest
San Diego, California, United States, 92103
Drug shipment address only-UCSF Medical Center-Mt. Zion/Pharmaceutical Services
San Francisco, California, United States, 94115
University of California, San Francisco: Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94115
Coastal Integrative Cancer Care
San Luis Obispo, California, United States, 93401
San Luis Obispo Oncology and Hematology Health Center/Pacific Central Coast Health Centers
San Luis Obispo, California, United States, 93401
Sm Luis Obispo Oncology and Hematology Health Center1 Pacific
San Luis Obispo, California, United States, 93401
Breastlink Medical Group, Inc.
Santa Ana, California, United States, 92705
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
Marian Regional Medical Center Laboratory
Santa Maria, California, United States, 93454
UCLA Hematology Oncology - Santa Monica
Santa Monica, California, United States, 90404
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center and Orthopaedic Hospital
Santa Monica, California, United States, 90404
City of Hope
South Pasadena, California, United States, 91030
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, United States, 91355
Wellness Oncology & Hematology
West Hills, California, United States, 91307
UCLA Hematology Oncology - Westlake
Westlake Village, California, United States, 91361
United States, Florida
University of Miami Hospitals and Clinics (UHMC) Sylvester at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, United States, 33308
Memorial Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Sylvester Comprehensive Cancer Center/ University of Miami Hospitals and Clinics
Miami, Florida, United States, 33136
Orlando Health, Inc
Orlando, Florida, United States, 32806
Memorial Breast Cancer Center at Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Memorial Hospital West
Pembroke Pines, Florida, United States, 33028
Sylvester at Plantation
Plantation, Florida, United States, 33324
United States, Georgia
Piedmont Cancer Institute, PC
Atlanta, Georgia, United States, 30318
Piedmont Cancer Institute, PC
Fayetteville, Georgia, United States, 30214
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Maine
Maine Center for Cancer Medicine, dba: New England Cancer Specialists
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine, dba: New England Cancer Specialist
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine, dba: New England Cancer Specialist
Kennebunk, Maine, United States, 04043
Maine Center for Cancer Medicine, dba: New England Cancer Specialists (Drug Shipment)
Scarborough, Maine, United States, 04074
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Perceptive Informatics
Billerica, Massachusetts, United States, 01821
United States, Michigan
University of Michigan Health System/Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Fairview Southdale Oncology Clinic
Edina, Minnesota, United States, 55435
Drug Shipment Address: University of Minnesota Medical Center, Fairview IDS Pharmacy
Minneapolis, Minnesota, United States, 55455
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455
University of Minnesota Physicians, Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin, Missouri, United States, 63011
Mercy Clinic St. Louis Cancer and Breast Institute
St. Louis, Missouri, United States, 63109
Mercy Hospital St. Louis
St. Louis, Missouri, United States, 63141
Mercy Hospital St.Louis- David C. Pratt Cancer Center
St. Louis, Missouri, United States, 63141
Mercy Clinic Mercy Oncology
Washington, Missouri, United States, 63090
Mercy Hospital Washington
Washington, Missouri, United States, 63090
United States, Nevada
Comprehensive Cancer Centers of Nevada Research Department
Henderson, Nevada, United States, 89014
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Mount Kisco Medical Group
Brewster, New York, United States, 10509
ProHEALTHCARE Associates, LLP
Lake Success, New York, United States, 11042
Mount Kisco Medical Group
Mount Kisco, New York, United States, 10549
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
United States, North Carolina
Hope Womens Cancer Centers
Asheville, North Carolina, United States, 28806
Mission Hospital, Inc.
Asheville, North Carolina, United States, 28806
United States, Pennsylvania
UPMC Cancer Center, Monroeville
Monroeville, Pennsylvania, United States, 15146
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
IP Preparation/Storage: Thomas Jefferson University, Investigative Drug Services
Philadelphia, Pennsylvania, United States, 19107
IP Shipment Address: Thomas Jefferson University, Investigational Drug Services
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University, Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Universsity of Pittsburgh Cancer Institute, Investigational Drug Service, William M. Cooper Pavilion
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
United States, Texas
Texas Oncology- Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Investigational Products Center (IPC) (Drug Shipment Only)
Fort Worth, Texas, United States, 76177
Texas Oncology- Longview Cancer Center
Longview, Texas, United States, 75601
Texas Oncology- McAllen South Second Street
McAllen, Texas, United States, 78503
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78212
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78258
Texas Oncology- Tyler
Tyler, Texas, United States, 75702
Texas Oncology- Weslaco
Weslaco, Texas, United States, 78596
United States, Utah
Huntsman Cancer Hospital
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Specialists, PC
Arlington, Virginia, United States, 22205
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States, 22903
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Inova Medical Group
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Leesburg, Virginia, United States, 20176
Shenandoah Oncology, P.C.
Winchester, Virginia, United States, 22601
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Swedish Medical Center Investigational Drug Services
Seattle, Washington, United States, 98122
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Columbia St. Mary's
Mequon, Wisconsin, United States, 53097
Columbia St. Mary's
Milwaukee, Wisconsin, United States, 53211
Australia, New South Wales
Bankstown - Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Queensland
River City Pharmacy
Auchenflower, Queensland, Australia, 4066
Sunshine Coast Hospital and Health Service
Nambour, Queensland, Australia, 4560
Icon Cancer Care Southport
Southport, Queensland, Australia, 4215
Australia, Victoria
Cabrini Brighton
Brighton, Victoria, Australia, 3186
Monash Health
Clayton, Victoria, Australia, 3168
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Peninsula and Southeast Oncology
Frankston, Victoria, Australia, 3199
Barwon Health - The Geelong Hospital - Clinical Trials Pharmacy
Geelong, Victoria, Australia, 3220
Barwon Health - The Geelong Hospital
Geelong, Victoria, Australia, 3220
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia, Western Australia
Fiona Stanley Hospital - Cancer Centre
Murdoch, Western Australia, Australia, 6150
Belgium
Clinique Saint-Pierre
Ottignies, Brabant Wallon, Belgium, 1340
Institut Jules Bordet
Bruxelles, Bruxelles Capitale, Belgium, 1000
Grand Hôpital de Charleroi - Site Notre Dame
Charleroi, Hainaut, Belgium, 6000
INDC Entité Jolimontoise - CH de Jolimont-Lobbes
Haine St. Paul, Hainaut, Belgium, 7100
CHWaPi - Site IMC
Tournai, Hainaut, Belgium, 7500
C.H. de l'Ardenne - site Libramont
Libramont-Chevigny, Luxembourg, Belgium, 6800
Hopital Erasme
Bruxelles, Region de Bruxelles-capital, Belgium, 1070
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Clinique et Maternité Sainte-Elisabeth
Namur, Belgium, 5000
GZA Ziekenhuizen - Campus St Augustinus
Wilrijk, Belgium, 2610
Canada, British Columbia
British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer Agency, Fraser Valley Cancer Centre
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Lakeridge Health Oshawa, R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
The Ottawa Hospital Cancer Centre, General Campus
Ottawa, Ontario, Canada, K1H 8L6
Niagara Health System Walker Family Cancer Centre
St. Catharines, Ontario, Canada, L2S 0A9
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Germany
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
Klinikum der Universität München
München, Germany, 80337
Sana Klinikum Offenbach
Offenbach, Germany, 63069
Ireland
Bon Secours Hospital
Cork, Ireland
Italy
Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata Farmacia Interna
Bagno a Ripoli (FI), Italy, 50012
S.O.C. Oncologia Medica I, Azienda Sanitaria Firenze, c/o Ospedale S. M. Annunziata
Bagno a Ripoli (FI), Italy, 50012
A.O.U. Policlinico SantOrsola
Bologna, Italy, 40138
SSD Oncologia Medica Addarii-Zamagni
Bologna, Italy, 40138
U.O. di Oncologia Medica P.O. Policlinico G. Rodolico"
Catania, Italy, 95123
Azienda U.L.S.S. n. 21 di Legnago, Presidio Ospedaliero Mater Salutis
Legnago (VR), Italy, 37045
Farmacia Ospedaliera-Azienda U.L.S.S. n. 21 di Legnago
Legnago (VR), Italy, 37045
IRST, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (FC), Italy, 47014
Farmacia IRCCS Ospedale San Raffaele
Milano, Italy, 20132
IRCCS Ospedale S. Raffaele
Milano, Italy, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
Istituto Europeo di Oncologia
Milano, Italy, 20141
Servizio di Farmacia - Istituto Europeo di Oncologia
Milano, Italy, 20141
Policlinico di Modena Dipartimento ad attivita integrata di Oncologia,
Modena, Italy, 41124
IRCCS Istituto Nazionale per lo Studio e la Cura dei Tumori
Napoli, Italy, 80131
Farmacia - Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168
Fondazione Policlinico Universitario A. Gemelli
Roma, Italy, 00168
S.C. Oncologia
Terni, Italy, 05100
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi,japan, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama-city, Ehime, Japan, 791-0280
Saitama Cancer Center
Kita-adachi-gun, Saitama,japan, Japan, 362-0806
Chiba Cancer Center
Chiba, Japan, 260-8717
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Japan, 892-0833
National Hospital Organization
Osaka, Japan, 540-0006
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Republic of Korea, Korea, Republic of, 03080
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan medical Center
Seoul, Korea, Republic of, 138-736
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Limburg, Netherlands, 6229 HX
Orbis Medisch Centrum
Sittard-Geleen, Limburg, Netherlands, 6162 BG
TweeSteden Ziekenhuis
Tilburg, Noord-brabant, Netherlands, 5042AD
Haga Ziekenhuis
Den Haag, Zuid-holland, Netherlands, 2545 CH
Leids Universitair Medisch Centrum
Leiden, Zuid-holland, Netherlands, 2333ZA
Ikazi Ziekenhuis
Rotterdam, Zuid-holland, Netherlands, 3083 AN
Portugal
Champalimaud Cancer Center/ Breast Unit
Lisboa, Portugal, 1400-038
Instituto Português de Oncologia
Porto, Portugal, 4200-072
Romania
Spitalul Municipal Ploiesti
Ploiesti, Romania, 100337
Spitalul Judetean de Urgente "Sf. Ioan cel Nou"
Suceava, Romania, 720237
Russian Federation
OGBUZ Belgorod Oncology Dispensary
Belgorod,, Belgorodskaya Oblast',, Russian Federation, 308010
OGBUZ Belgorod Oncology Dispensary
Stariy Oskol, Belgorodskaya Oblast', Russian Federation, 309504
GBUZ Leningrad regional oncological dispensary
village Kuzmolovsky, Leningradskaya Oblast', Russian Federation, 188663
FGBU Russian Research Center for Radiology and Surgical Technologies
village Pesochny, Leningradskaya Oblast', Russian Federation, 197758
GBUZ Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Bashkortostan
Ufa, Republic of Bashkortostan, Russian Federation, 450054
FGBUZ Clinical Hospital 101 of the Federal Medical and Biological Agency"
Lermontov, Stavropol Territory, Russian Federation, 357340
GBUZ of Stavropol Territory Pyatigorsk Oncology Dispensary
Pyatigorsk,, Stavropol Territory, Russian Federation, 357502
FSBSI Russian Cancer Research Center n.a.NN Blokhin
Moscow, Russian Federation, 115478
Saint Petersburg GBUZ "City Clinical Oncology Dispensary"
Saint Petersburg, Russian Federation, 197022
Saint Petersburg GBUZ City Clinical Oncology Dispensary
Saint Petersburg, Russian Federation, 198255
GBUZ of Stavropol Territory "Stavropol Regional Clinical Oncology Dispensary"
Stavropol, Russian Federation, 355047
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Turkey
Ege University Medical Faculty
Izmir, Bornova, Turkey, 35040
Ukraine
Komunalnyi zaklad, 'Dnipropetrovska miska bahatoprofilna klinichna likarnia No.4
Dnipropetrovsk, Ukraine, 49102
Komunalnyi zaklad okhorony zdorovia "Kharkivskyi oblasnyi klinichnyi onkolohichnyi tsentr"
Kharkiv, Ukraine, 61070
Lvivskyi derzhavnyi onkolohichnyi rehionalnyi likuvalno-diahnostychnyi tsentr
Lviv, Ukraine, 79031
Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser
Vinnytsia, Ukraine, 21029
United Kingdom
Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust Portsmouth Haematology and Oncology Centre
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Research and Development Department - Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Velindre Cancer Centre
Cardiff, South Glamorgan, United Kingdom, CF14 2TL
Sheffield Teaching Hospitals NHS Foundation Trust, Weston Park Hospital
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Pfizer
AstraZeneca
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01942135     History of Changes
Other Study ID Numbers: A5481023  2013-002580-26 
Study First Received: September 10, 2013
Results First Received: December 3, 2015
Last Updated: July 13, 2016
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
Goserelin
Palbociclib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016