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

Primary Purpose

Breast Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PD-0332991

Letrozole

Placebo

Letrozole

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring breast cancer, postmenopausal women, estrogen-receptor positive, HER2 negative, locoregionally recurrent, metastatic, Palbociclib (PD-0332991), PALOMA-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Confirmed diagnosis of HER2 positive disease
Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
Known uncontrolled or symptomatic CNS metastases
Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
Prior treatment with any CDK 4/6 inhibitor.

Sites / Locations

Southern California Permanente Medical Group
Beverly Hills Cancer Center
St. Joseph Heritage Healthcare
Los Angeles Hematology/Oncology Medical Group
UCLA Hematology/ Oncology- Irvine
UCLA Hematology Oncology- Laguna Hills
Los Angeles Hematology/Oncology Medical Group
Southern California Permanente Medical Group
Translational Research Management
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
UCLA West Medical Pharmacy, Attn: Steven L. Wong
UCLA West Medical Pharmacy: Drug Management Only
UCLA West Medical Pharmacy; Drug Management Only
UCLA West Medical Pharmacy
Administrative Address: UCLA Hematology/Oncology
Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.
Regulatory Management Only: TRIO-US Central Administration
Ronald Reagan UCLA Medical Center
TRIO-US Central Administration: Regulatory Management Only
TRIO-US Central Administration
UCLA Hematology Oncology
UCLA Hematology/Oncology
UCLA Hematology/ Oncology- Pasadena
Torrance Health Association, DBa Torrance Memorial Physician Network
Southern California Permanente Medical Group
University of California, San Francisco
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers
Central Coast Medical Oncology Corporation
UCLA Santa Monica Medical Center and Orthopaedic Hospital
Stanford Women's Cancer Center
Wellness Oncology & Hematology
UCLA Hematology/Oncology- Westlake
St. Mary's Hospital Regional Cancer Center
Smilow Cancer Hospital at Yale New Haven
Whittingham Cancer Center @ Norwalk Hospital
MedStar Georgetown University Hospital
Sylvester at Deerfield Beach
Memorial Breast Cancer Center at Memorial Regional Hospital
Memorial Cancer Institute at Memorial Regional Hospital
Memorial Regional Hospital
Cancer Specialist of North Florida, Pharmacy
Cancer Specialists of North Florida-Southpoint
Orlando Health, Inc.
Memorial Breast Cancer Center at Memorial Hospital West
Memorial Cancer Institute at Memorial Hospital West
Memorial Hospital West
Sylvester Comprehensive Cancer Center Plantation
Cancer Specialists of North Florida - St. Augustine
Grady Health System
Emory University Hospital Midtown
Emory University Hospital
The Emory Clinic
Winship Cancer Institute
Northwest Georgia Oncology Centers, PC
Kootenai Clinic Cancer Services
Kootenai Clinic Cancer Services
The Mark M. Connolly Center for Cancer and Specialty Care
Carle Foundation Hospital DBA Carle Cancer Center
Carle Foundation Hospital DBA Carle Cancer Center
Presence Infusion Care- Evanston
Carle Foundation Hospital DBA Carle Cancer Center
Presence Infusion Care- Skokie
Carle Foundation Hospital DBA Carle Cancer Center
James Graham Brown Cancer Center and University Hospital
James Graham Brown Cancer Center
University of Maryland, Greenebaum Cancer Center
Walter Reed National Military Medical Center
University of Michigan Health System
Park Nicollet Frauenshuh Cancer Center
The West Clinic, PC
The West Clinic, PC dba West Cancer Centre
Mercy Clinic St. Louis Cancer and Breast Institute
Mercy Clinic St. Louis Cancer and Breast Institute
Mercy Hospital St. Louis - David C. Pratt Cancer Center
Mercy Hospital St. Louis
Saint Francis Medical Center
Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Saint Francis Medical Center
Comprehensive Cancer Centers of Nevada
Comprehensive Cancer Centers of Nevada
Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department
Comprehensive Cancer Centers of Nevada
Comprehensive Cancer Centers of Nevada
Comprehensive Cancer Centers of Nevada
CareMount Medical
CareMount Medical
Northern Westchester Hospital
Columbia University Medical Center
Stony Brook University- Cancer Center
Northwest Cancer Specialists, PC
Kaiser Permanente Northwest Region
Northwest Cancer Specialists, P.C.
OHSU Center for Health and Healing 2
OHSU Center for Health and Healing
OHSU Research Pharmacy Services
Oregon Health and Science University
Tennessee Oncology, PLLC
Tennessee Oncology PLLC
Tennessee Oncology, PLLC
The West Clinic, PC dba West Cancer Centre
Tennessee Oncology PLLC
Tennessee Oncology, PLLC
The West Clinic, PC dba West Cancer Centre
Tennessee Oncology PLLC
Sarah Cannon Research Institute
Tennessee Oncology, PLLC
Tennessee Oncology PLLC
Tennessee Oncology PLLC
Tennessee Oncology PLLC
Tennessee Oncology, PLLC
Tennessee Oncology PLLC
Texas Oncology-Dallas Presbyterian Hospital
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Texas oncology-west Texas
Texas oncology-West Texas
Texas Oncology-west Texas
Investigational Products Center (IPC)
The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
The University of Texas MD Anderson Cancer Center.
The University of Texas MD Anderson Cancer Center
US Oncology Investigational Products Center
Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Virginia Oncology Associates
Virginia oncology Associates
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Virginia Oncology Associates
Shenandoah Oncology PC
Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
Seattle Cancer Care Alliance
Northwest Cancer Specialists, P.C.
Northwest Cancer Specialists P.C.
WVU Medicine
University of Wisconsin
St Vincent's Hospital Sydney
Laverty Pathology
Mid North Coast Diagnostic Imaging
Calvary Mater Newcastle
Icon Cancer Care
Sunshine Coast University Hospital
Icon Cancer Care Corporate Office
Princess Alexandra Hospital
Royal Adelaide Hospital
Bendigo Health Care Group, The Bendigo Hospital Campus
Northern Hospital
Royal Melbourne Hospital
Epworth Healthcare
Maroondah Hospital
Goulburn Valley Health
Fiona Stanley Hospital
Gasthuis Zusters Antwerpen - Campus Sint- Augustinus
Institut Jules Bordet
Oncologie
UZ Brussel
Grand Hopital de Charleroi / Service d'Hematologie et Oncologie
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
CHU Start Tilman
CHR East Belgium - Verviers
Tom Baker Cancer Centre
Cross Cancer Institute
BC Cancer Agency-Fraser Valley Centre
British Columbia Cancer Agency-Vancouver Centre
QEII Health Sciences Centre, Victoria General Site
London Regional Cancer Program
Southlake Regional Health Centre- Stronach Regional Cancer Centre
Sunnybrook Research Institute
St. Michaels Hospital
Princess Margaret Cancer Centre
McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
Hopital du Sacre-Coeur
Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement
Allan Blair Cancer Centre
Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie
Institut de Cancerologie de l'Ouest- Paul Papin
Centre François Baclesse
Centre Georges François Leclerc
CHD Vendée
Centre Val d'Aurelle,
Centre Antoine Lacassagne
Institut Curie, Departement d'Oncologie Medicale
Centre Eugene Marquis
Hopital Rene Huguenin/Institut Curie
Institut de Cancérologie de l'Ouest-Rene Gauducheau
Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department
Institut Gustave Roussy
IOZ- Munchen, PGM- Studien GmbH
Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen
University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.
Universitatsklinikum Erlangen, Frauenklinik
Universitaetsklinikum Hamburg-Eppendorf
Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe
Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik
Katholisches Klinikum Mainz
Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen
Rotkreuzklinikum Munchen, Frauenklinik,
Breast Cancer, University of Munich, Grosshadern Hospital
Klinikum Mutterhaus
Szent Margit Korhaz
Affidea Diagnosztika Kft.
Orszagos Onkologiai Intezet ,
Országos Onkológiai Intézet "B" Belgyogyaszati osztaly
Országos Onkológiai Intézet, Nuklearis Medicina Osztaly
Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily
Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly
Josa Andras Teaching Hospital,
Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar
Diagnoscan Magyarorszag Kft.
Bon Secours Hospital
St Vincents University Hospital
St. James Hospital
Beaumont Hospital
Mater Misericordiae University Hospital
Department of Medical Oncology
Mid Western Regional Hospital
Waterford Regional Hospital
Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi
Irccs Irst
IRCCS - Istituto Europeo di Oncologia
Azienda Ospedaliera San Giuseppe Moscati
Azienda Ospedaliero-Universitaria Pisana
Istituti Fisioterapici Ospitalieri
Ospedale SS Trinita
Aichi Cancer Center Hospital
National Cancer Center Hospital East
National Hospital Organization Shikoku Cancer Center
National Hospital Organization Hokkaido Cancer Center
Kumamoto City Hospital
Saitama Cancer Center
National Cancer Center Hospital
Chiba Cancer Center
National Hospital Organization Kyushu Cancer Center
Hiroshima City Hiroshima Citizens Hospital
Iwate Medical University Hospital
Hakuaikai Medical Corporation Sagara Hospital
Kumamoto University Hospital
Niigata Cancer Center Hospital 2-15-3
National Hospital Organization Osaka National Hospital
National Cancer Center, Center for Breast Cancer
Seoul National University Bundang Hospital
Severance Hospital, Yonsei University Health System
Seoul National University Hospital / Department of Internal Medicine
Asan Medical Center, Division of Oncology, Department of Internal Medicine
Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine
Europejskie Centrum Zdrowia Otwock
Oncology and Radiotherapy Clinic
Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian
Regional Budgetary Healthcare Institution Kursk Regional Clinical
State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"
GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan
State Budget Healthcare Institution Moscow City Oncology Hospital
Federal State Budget Institution
Budget Institution of Healthcare
Budget Institution of Healthcare
Ryazan Regional Clinical Oncology Dispensary
Saint-Petersburg State Budget Healthcare Institution (SBHCI)
Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways
Republican Clinical Hospital n.a. G.G. Kuvatov
State Budget Medical Institution Republican Clinical Oncology
SBHI of Republic of Bashkortostan Emergency Hospital
Hospital Universitari Germans Trias i Pujol
Consorci Sanitari de Terrassa
Hospital Universitari Son Espases
Hospital Universitario Fundacion de Alcorcon
Hospital Universitario de Canarias
Hospital Universitario Infanta Cristina
Hospital del Mar
Hospital Universitari Vall d'Hebron
Hospital Clinic I Provincial
Hospital de Donostia
Complejo Hospitalario de Jaen
Instituto Catalan de Oncologia L'Hospitalet
Centro Oncologico de Galicia
Hospital Universitario Arnau de Vilanova de Lleida
Hospital General Universitario Gregorio Marañon
Centro Oncologico MD Anderson Internacional España
Hospital Clinico San Carlos
HOSPITAL Universitario 12 DE OCTUBRE
Hospital Madrid Universitario Sanchinarro
Hospital Universitario Virgen Macarena
Hospital Universitario Virgen del Rocio
Instituto Valenciano de Oncologia
National Taiwan University Hospital
Veterans General Hospital-Taipei
Mackay Memory Hospital
MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council
State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine
Municipal Non-profit Enterprise "Regional Centre of Oncology"
Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department
Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"
Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department
City Oncology Centre of Central Municipal Clinical Hospital
Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.
MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,
State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",
Kent Oncology Center
Edinburgh Cancer Centre, Western General Hospital
Beatson Institute for Cancer Research
Guys Hospital
The Royal Marsden NHS Foundation Trust
Charing Cross Hospital
Christie Hospital NHS Foundation Trust
The Research And Development Office, The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PD-0332991 + Letrozole

Placebo + Letrozole

Arm Description

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) as Assessed by the Investigator.

PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.

Secondary Outcome Measures

Objective Response as Assessed by the Investigator

Objective Response (OR) defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator

The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

Duration of Response (DR)

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 will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

Disease Control (DC)/Clinical Benefit Response (CBR)

DC is defined as the overall CR, PR, or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD ≥24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD≥24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD≥24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression

PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)

PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score ≥1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.

Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.

Percentage of Participants With Corrected QT Interval (QTc)

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.

Observed Plasma Trough Concentration (Ctrough) at Steady-State

Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.

Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).

Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)

FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization; resulted in persistent or significant disability or in congenital anomaly/birth defect. TEAE were events that occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Severity was graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening and Grade 5 = death related to AE.

Overall Survival (OS)

OS was defined as the time from date of randomization to date of death due to any cause. Participants without survival data beyond the date of their last follow-up were censored on the last date they were known to be alive.

Survival Probability at 1 Year, 2 Year and 3 Year

One, two or three-year survival probability was defined as the probability of survival 1 year, 2 or 3 years after the date of randomization. The survival probability was estimated using the Kaplan-Meier method and 2-sided 95% confidence interval (CI) was calculated using the product limit method.

Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade

Laboratory abnormalities included anemia, hemoglobin increased, neutrophils (absolute), platelets, white blood cells, alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormalities were graded by CTCAE version (v) 4.0 as Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life-threatening. Categories with at least 1 non-zero data values are reported.

Full Information

NCT ID

NCT01740427

First Posted

November 26, 2012

Last Updated

December 6, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01740427

Brief Title

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

Official Title

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 22, 2013 (Actual)

Primary Completion Date

February 26, 2016 (Actual)

Study Completion Date

August 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

breast cancer, postmenopausal women, estrogen-receptor positive, HER2 negative, locoregionally recurrent, metastatic, Palbociclib (PD-0332991), PALOMA-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

666 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PD-0332991 + Letrozole

Arm Type

Experimental

Arm Description

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Arm Title

Placebo + Letrozole

Arm Type

Active Comparator

Arm Description

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment in combination with Letrozole, 2.5mg, orally once daily (continuously).

Intervention Type

Drug

Intervention Name(s)

PD-0332991

Intervention Description

PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Description

Letrozole, 2.5mg, orally once daily (continuously)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Description

Letrozole, 2.5mg, orally once daily (continuously)

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS) as Assessed by the Investigator.

Description

Time Frame

From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)

Secondary Outcome Measure Information:

Title

Objective Response as Assessed by the Investigator

Description

Time Frame

From randomization until end of treatment (up to approximately 2.5 years)

Title

Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator

Description

Time Frame

From randomization until end of treatment (up to approximately 2.5 years)

Title

Duration of Response (DR)

Description

Time Frame

From randomization until end of treatment (up to approximately 2.5 years)

Title

Disease Control (DC)/Clinical Benefit Response (CBR)

Description

Time Frame

From randomization until end of treatment (up to approximately 2.5 years)

Title

PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)

Description

Time Frame

From randomization until end of treatment (up to approximately 24 Months)

Title

Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14

Description

Time Frame

Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14

Title

Percentage of Participants With Corrected QT Interval (QTc)

Description

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.

Time Frame

For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated

Title

Observed Plasma Trough Concentration (Ctrough) at Steady-State

Description

Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.

Time Frame

0 hour (predose) on Day 14 of cycles 1 and 2

Title

Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

Description

Time Frame

From Baseline up to 2.5 years

Title

Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)

Description

Time Frame

From Baseline up to 2.5 years

Title

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)

Description

Time Frame

From date of randomization up to 28 days after last dose of study drug, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)

Title

Overall Survival (OS)

Description

Time Frame

From date of randomization until death due to any cause or censored, (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)

Title

Survival Probability at 1 Year, 2 Year and 3 Year

Description

Time Frame

1, 2 and 3 years after randomization

Title

Number of Participants With Laboratory Abnormalities by Maximum Common Terminology Criteria for Adverse Events (CTCAE) Grade

Description

Time Frame

From randomization up to 28 days after last dose of study drug (assessed up to data cut-off date of 15-Nov-2021, approximately 8.7 years)

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. Confirmed diagnosis of ER positive breast cancer No prior systemic anti-cancer therapy for advanced ER+ disease. Postmenopausal women Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease Eastern Cooperative Oncology Group [ECOG] 0-2 Adequate organ and marrow function Patient must agree to provide tumor tissue Exclusion Criteria: Confirmed diagnosis of HER2 positive disease Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term Known uncontrolled or symptomatic CNS metastases Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment. Prior treatment with any CDK 4/6 inhibitor.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Southern California Permanente Medical Group

City

Bellflower

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

Beverly Hills Cancer Center

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

St. Joseph Heritage Healthcare

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Los Angeles Hematology/Oncology Medical Group

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

Facility Name

UCLA Hematology/ Oncology- Irvine

City

Irvine

State/Province

California

ZIP/Postal Code

92604

Country

United States

Facility Name

UCLA Hematology Oncology- Laguna Hills

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Los Angeles Hematology/Oncology Medical Group

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Southern California Permanente Medical Group

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

Facility Name

Translational Research Management

City

Los Angeles

State/Province

California

ZIP/Postal Code

90045

Country

United States

Facility Name

Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-1772

Country

United States

Facility Name

UCLA West Medical Pharmacy, Attn: Steven L. Wong

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-7349

Country

United States

Facility Name

UCLA West Medical Pharmacy: Drug Management Only

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-7349

Country

United States

Facility Name

UCLA West Medical Pharmacy; Drug Management Only

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-7349

Country

United States

Facility Name

UCLA West Medical Pharmacy

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-7349

Country

United States

Facility Name

Administrative Address: UCLA Hematology/Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Regulatory Management Only: TRIO-US Central Administration

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Ronald Reagan UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

TRIO-US Central Administration: Regulatory Management Only

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

TRIO-US Central Administration

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA Hematology Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA Hematology/Oncology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

UCLA Hematology/ Oncology- Pasadena

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Torrance Health Association, DBa Torrance Memorial Physician Network

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Southern California Permanente Medical Group

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

UCLA Santa Monica Medical Center and Orthopaedic Hospital

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Stanford Women's Cancer Center

City

Stanford

State/Province

California

ZIP/Postal Code

94304-5826

Country

United States

Facility Name

Wellness Oncology & Hematology

City

West Hills

State/Province

California

ZIP/Postal Code

91307

Country

United States

Facility Name

UCLA Hematology/Oncology- Westlake

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

St. Mary's Hospital Regional Cancer Center

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81501

Country

United States

Facility Name

Smilow Cancer Hospital at Yale New Haven

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Whittingham Cancer Center @ Norwalk Hospital

City

Norwalk

State/Province

Connecticut

ZIP/Postal Code

06856

Country

United States

Facility Name

MedStar Georgetown University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Sylvester at Deerfield Beach

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33442

Country

United States

Facility Name

Memorial Breast Cancer Center at Memorial Regional Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Memorial Cancer Institute at Memorial Regional Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Memorial Regional Hospital

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Cancer Specialist of North Florida, Pharmacy

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Cancer Specialists of North Florida-Southpoint

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Orlando Health, Inc.

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Memorial Breast Cancer Center at Memorial Hospital West

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Memorial Cancer Institute at Memorial Hospital West

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Memorial Hospital West

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Sylvester Comprehensive Cancer Center Plantation

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Cancer Specialists of North Florida - St. Augustine

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

Grady Health System

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Emory University Hospital Midtown

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

The Emory Clinic

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Winship Cancer Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Northwest Georgia Oncology Centers, PC

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Kootenai Clinic Cancer Services

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Kootenai Clinic Cancer Services

City

Post Falls

State/Province

Idaho

ZIP/Postal Code

83854

Country

United States

Facility Name

The Mark M. Connolly Center for Cancer and Specialty Care

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

Carle Foundation Hospital DBA Carle Cancer Center

City

Danville

State/Province

Illinois

ZIP/Postal Code

61832

Country

United States

Facility Name

Carle Foundation Hospital DBA Carle Cancer Center

City

Effingham

State/Province

Illinois

ZIP/Postal Code

62401

Country

United States

Facility Name

Presence Infusion Care- Evanston

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60202

Country

United States

Facility Name

Carle Foundation Hospital DBA Carle Cancer Center

City

Mattoon

State/Province

Illinois

ZIP/Postal Code

61938

Country

United States

Facility Name

Presence Infusion Care- Skokie

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Carle Foundation Hospital DBA Carle Cancer Center

City

Urbana

State/Province

Illinois

ZIP/Postal Code

61801

Country

United States

Facility Name

James Graham Brown Cancer Center and University Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

University of Maryland, Greenebaum Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Walter Reed National Military Medical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20889-5600

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Park Nicollet Frauenshuh Cancer Center

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55426

Country

United States

Facility Name

The West Clinic, PC

City

Corinth

State/Province

Mississippi

ZIP/Postal Code

38834

Country

United States

Facility Name

The West Clinic, PC dba West Cancer Centre

City

Southaven

State/Province

Mississippi

ZIP/Postal Code

38671

Country

United States

Facility Name

Mercy Clinic St. Louis Cancer and Breast Institute

City

Ballwin

State/Province

Missouri

ZIP/Postal Code

63011

Country

United States

Facility Name

Mercy Clinic St. Louis Cancer and Breast Institute

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63109

Country

United States

Facility Name

Mercy Hospital St. Louis - David C. Pratt Cancer Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Mercy Hospital St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Saint Francis Medical Center

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68802

Country

United States

Facility Name

Saint Francis Medical Center, Saint Francis Cancer Treatment Center

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68803

Country

United States

Facility Name

Saint Francis Medical Center

City

Hastings

State/Province

Nebraska

ZIP/Postal Code

68901

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074-8195

Country

United States

Facility Name

Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

CareMount Medical

City

Brewster

State/Province

New York

ZIP/Postal Code

10509

Country

United States

Facility Name

CareMount Medical

City

Mount Kisco

State/Province

New York

ZIP/Postal Code

10549

Country

United States

Facility Name

Northern Westchester Hospital

City

Mount Kisco

State/Province

New York

ZIP/Postal Code

10549

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Stony Brook University- Cancer Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794-9447

Country

United States

Facility Name

Northwest Cancer Specialists, PC

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Kaiser Permanente Northwest Region

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Northwest Cancer Specialists, P.C.

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

OHSU Center for Health and Healing 2

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

OHSU Center for Health and Healing

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

OHSU Research Pharmacy Services

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Dickson

State/Province

Tennessee

ZIP/Postal Code

37055

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Gallatin

State/Province

Tennessee

ZIP/Postal Code

37066

Country

United States

Facility Name

The West Clinic, PC dba West Cancer Centre

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Hermitage

State/Province

Tennessee

ZIP/Postal Code

37076

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Lebanon

State/Province

Tennessee

ZIP/Postal Code

37090

Country

United States

Facility Name

The West Clinic, PC dba West Cancer Centre

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38104

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Murfreesboro

State/Province

Tennessee

ZIP/Postal Code

37129

Country

United States

Facility Name

Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37207

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37211

Country

United States

Facility Name

Tennessee Oncology, PLLC

City

Shelbyville

State/Province

Tennessee

ZIP/Postal Code

37160

Country

United States

Facility Name

Tennessee Oncology PLLC

City

Smyrna

State/Province

Tennessee

ZIP/Postal Code

37167

Country

United States

Facility Name

Texas Oncology-Dallas Presbyterian Hospital

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Texas Oncology-Baylor Charles A. Sammons Cancer Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Texas oncology-west Texas

City

El Paso

State/Province

Texas

ZIP/Postal Code

79902

Country

United States

Facility Name

Texas oncology-West Texas

City

El Paso

State/Province

Texas

ZIP/Postal Code

79915

Country

United States

Facility Name

Texas Oncology-west Texas

City

El Paso

State/Province

Texas

ZIP/Postal Code

79938

Country

United States

Facility Name

Investigational Products Center (IPC)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76177

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center.

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

US Oncology Investigational Products Center

City

Irving

State/Province

Texas

ZIP/Postal Code

75063

Country

United States

Facility Name

Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

City

Blacksburg

State/Province

Virginia

ZIP/Postal Code

24060

Country

United States

Facility Name

Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

City

Low Moor

State/Province

Virginia

ZIP/Postal Code

24457

Country

United States

Facility Name

Virginia Oncology Associates

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Virginia oncology Associates

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

City

Salem

State/Province

Virginia

ZIP/Postal Code

24153

Country

United States

Facility Name

Virginia Oncology Associates

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Facility Name

Shenandoah Oncology PC

City

Winchester

State/Province

Virginia

ZIP/Postal Code

22601

Country

United States

Facility Name

Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

City

Wytheville

State/Province

Virginia

ZIP/Postal Code

24382

Country

United States

Facility Name

Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Northwest Cancer Specialists, P.C.

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98683

Country

United States

Facility Name

Northwest Cancer Specialists P.C.

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

WVU Medicine

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-6164

Country

United States

Facility Name

St Vincent's Hospital Sydney

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Laverty Pathology

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Facility Name

Mid North Coast Diagnostic Imaging

City

Port Macquarie

State/Province

New South Wales

ZIP/Postal Code

2444

Country

Australia

Facility Name

Calvary Mater Newcastle

City

Waratah

State/Province

New South Wales

ZIP/Postal Code

2298

Country

Australia

Facility Name

Icon Cancer Care

City

Auchenflower

State/Province

Queensland

ZIP/Postal Code

4066

Country

Australia

Facility Name

Sunshine Coast University Hospital

City

Birtinya

State/Province

Queensland

ZIP/Postal Code

4575

Country

Australia

Facility Name

Icon Cancer Care Corporate Office

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Princess Alexandra Hospital

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Bendigo Health Care Group, The Bendigo Hospital Campus

City

Bendigo

State/Province

Victoria

ZIP/Postal Code

3550

Country

Australia

Facility Name

Northern Hospital

City

Epping

State/Province

Victoria

ZIP/Postal Code

3076

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Epworth Healthcare

City

Richmond

State/Province

Victoria

ZIP/Postal Code

3121

Country

Australia

Facility Name

Maroondah Hospital

City

Ringwood East

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

Goulburn Valley Health

City

Shepparton

State/Province

Victoria

ZIP/Postal Code

3630

Country

Australia

Facility Name

Fiona Stanley Hospital

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Gasthuis Zusters Antwerpen - Campus Sint- Augustinus

City

Wilrijk

State/Province

Antwerpen

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Oncologie

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Grand Hopital de Charleroi / Service d'Hematologie et Oncologie

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU Start Tilman

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

CHR East Belgium - Verviers

City

Verviers

ZIP/Postal Code

4800

Country

Belgium

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

BC Cancer Agency-Fraser Valley Centre

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 1Z2

Country

Canada

Facility Name

British Columbia Cancer Agency-Vancouver Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

QEII Health Sciences Centre, Victoria General Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

London Regional Cancer Program

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Southlake Regional Health Centre- Stronach Regional Cancer Centre

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y2P9

Country

Canada

Facility Name

Sunnybrook Research Institute

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

St. Michaels Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Hopital du Sacre-Coeur

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1S 4L8

Country

Canada

Facility Name

Allan Blair Cancer Centre

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Institut de Cancerologie de l'Ouest- Paul Papin

City

Anger Cedex 02

ZIP/Postal Code

49055

Country

France

Facility Name

Centre François Baclesse

City

Caen Cedex 5

ZIP/Postal Code

14076

Country

France

Facility Name

Centre Georges François Leclerc

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

CHD Vendée

City

La Roche Sur Yon

ZIP/Postal Code

85295

Country

France

Facility Name

Centre Val d'Aurelle,

City

Montpellier CEDEX 5

ZIP/Postal Code

34298

Country

France

Facility Name

Centre Antoine Lacassagne

City

Nice cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Institut Curie, Departement d'Oncologie Medicale

City

Paris Cedex 05

ZIP/Postal Code

75248

Country

France

Facility Name

Centre Eugene Marquis

City

Rennes

ZIP/Postal Code

35042

Country

France

Facility Name

Hopital Rene Huguenin/Institut Curie

City

Saint-Cloud

ZIP/Postal Code

92210

Country

France

Facility Name

Institut de Cancérologie de l'Ouest-Rene Gauducheau

City

St Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department

City

Toulouse CEDEX-9

ZIP/Postal Code

31059

Country

France

Facility Name

Institut Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

IOZ- Munchen, PGM- Studien GmbH

City

Muenchen

State/Province

Bavaria

ZIP/Postal Code

80336

Country

Germany

Facility Name

Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen

City

Boblingen

ZIP/Postal Code

71032

Country

Germany

Facility Name

University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitatsklinikum Erlangen, Frauenklinik

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Universitaetsklinikum Hamburg-Eppendorf

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik

City

Magdeburg

ZIP/Postal Code

39108

Country

Germany

Facility Name

Katholisches Klinikum Mainz

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Rotkreuzklinikum Munchen, Frauenklinik,

City

Munich

ZIP/Postal Code

80637

Country

Germany

Facility Name

Breast Cancer, University of Munich, Grosshadern Hospital

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

Klinikum Mutterhaus

City

Trier

ZIP/Postal Code

54290

Country

Germany

Facility Name

Szent Margit Korhaz

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Affidea Diagnosztika Kft.

City

Budapest

ZIP/Postal Code

1054

Country

Hungary

Facility Name

Orszagos Onkologiai Intezet ,

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Országos Onkológiai Intézet "B" Belgyogyaszati osztaly

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Országos Onkológiai Intézet, Nuklearis Medicina Osztaly

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly

City

Györ

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Josa Andras Teaching Hospital,

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Diagnoscan Magyarorszag Kft.

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Bon Secours Hospital

City

Cork

Country

Ireland

Facility Name

St Vincents University Hospital

City

Dublin 4

Country

Ireland

Facility Name

St. James Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Beaumont Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Mater Misericordiae University Hospital

City

Dublin

ZIP/Postal Code

Dublin 7

Country

Ireland

Facility Name

Department of Medical Oncology

City

Galway

Country

Ireland

Facility Name

Mid Western Regional Hospital

City

Limerick

Country

Ireland

Facility Name

Waterford Regional Hospital

City

Waterford

Country

Ireland

Facility Name

Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Irccs Irst

City

Meldola

State/Province

ZIP/Postal Code

47014

Country

Italy

Facility Name

IRCCS - Istituto Europeo di Oncologia

City

Milano

State/Province

Milan

ZIP/Postal Code

20141

Country

Italy

Facility Name

Azienda Ospedaliera San Giuseppe Moscati

City

Avellino

ZIP/Postal Code

83100

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Istituti Fisioterapici Ospitalieri

City

Roma

ZIP/Postal Code

00128

Country

Italy

Facility Name

Ospedale SS Trinita

City

Sora (FR)

ZIP/Postal Code

03039

Country

Italy

Facility Name

Aichi Cancer Center Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

National Cancer Center Hospital East

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

National Hospital Organization Shikoku Cancer Center

City

Matsuyama-city

State/Province

Ehime

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

National Hospital Organization Hokkaido Cancer Center

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Kumamoto City Hospital

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

862-8505

Country

Japan

Facility Name

Saitama Cancer Center

City

Kita-adachi-gun

State/Province

Saitama

ZIP/Postal Code

362-0806

Country

Japan

Facility Name

National Cancer Center Hospital

City

Chuo-Ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Chiba Cancer Center

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

National Hospital Organization Kyushu Cancer Center

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Hiroshima City Hiroshima Citizens Hospital

City

Hiroshima

ZIP/Postal Code

730-8518

Country

Japan

Facility Name

Iwate Medical University Hospital

City

Iwate

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

Hakuaikai Medical Corporation Sagara Hospital

City

Kagoshima

ZIP/Postal Code

892-0833

Country

Japan

Facility Name

Kumamoto University Hospital

City

Kumamoto

ZIP/Postal Code

860-8556

Country

Japan

Facility Name

Niigata Cancer Center Hospital 2-15-3

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Facility Name

National Hospital Organization Osaka National Hospital

City

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

National Cancer Center, Center for Breast Cancer

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seodaemun-gu

State/Province

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Seoul National University Hospital / Department of Internal Medicine

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Asan Medical Center, Division of Oncology, Department of Internal Medicine

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Europejskie Centrum Zdrowia Otwock

City

Otwock

State/Province

Mazovia

ZIP/Postal Code

05-400

Country

Poland

Facility Name

Oncology and Radiotherapy Clinic

City

Gdańsk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian

City

Zory

ZIP/Postal Code

44-240

Country

Poland

Facility Name

Regional Budgetary Healthcare Institution Kursk Regional Clinical

City

Kursk

State/Province

Kursk Region

ZIP/Postal Code

305524

Country

Russian Federation

Facility Name

State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"

City

Kuzmolovo

State/Province

Leningrad Region

ZIP/Postal Code

188663

Country

Russian Federation

Facility Name

GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

State Budget Healthcare Institution Moscow City Oncology Hospital

City

Moscow Area

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

Federal State Budget Institution

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Budget Institution of Healthcare

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Budget Institution of Healthcare

City

Omsk

ZIP/Postal Code

644046

Country

Russian Federation

Facility Name

Ryazan Regional Clinical Oncology Dispensary

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Saint-Petersburg State Budget Healthcare Institution (SBHCI)

City

Saint-Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways

City

St Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Republican Clinical Hospital n.a. G.G. Kuvatov

City

Ufa

ZIP/Postal Code

450005

Country

Russian Federation

Facility Name

State Budget Medical Institution Republican Clinical Oncology

City

Ufa

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

SBHI of Republic of Bashkortostan Emergency Hospital

City

Ufa

ZIP/Postal Code

450106

Country

Russian Federation

Facility Name

Hospital Universitari Germans Trias i Pujol

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Consorci Sanitari de Terrassa

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08227

Country

Spain

Facility Name

Hospital Universitari Son Espases

City

Palma de Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07010

Country

Spain

Facility Name

Hospital Universitario Fundacion de Alcorcon

City

Alcorcon

State/Province

Madrid

ZIP/Postal Code

28922

Country

Spain

Facility Name

Hospital Universitario de Canarias

City

La Laguna

State/Province

Santa CRUZ DE Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital Universitario Infanta Cristina

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clinic I Provincial

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital de Donostia

City

Donostia- San Sebastian

ZIP/Postal Code

20014

Country

Spain

Facility Name

Complejo Hospitalario de Jaen

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Instituto Catalan de Oncologia L'Hospitalet

City

L'Hospitalet De Llobregat (Barcelona)

ZIP/Postal Code

08908

Country

Spain

Facility Name

Centro Oncologico de Galicia

City

La Coruna

ZIP/Postal Code

15009

Country

Spain

Facility Name

Hospital Universitario Arnau de Vilanova de Lleida

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Centro Oncologico MD Anderson Internacional España

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Hospital Clinico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

HOSPITAL Universitario 12 DE OCTUBRE

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Hospital Madrid Universitario Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Instituto Valenciano de Oncologia

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

National Taiwan University Hospital

City

Taipei City

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Veterans General Hospital-Taipei

City

Taipei City

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Mackay Memory Hospital

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Municipal Non-profit Enterprise "Regional Centre of Oncology"

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"

City

Makiivka

ZIP/Postal Code

86120

Country

Ukraine

Facility Name

Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

City Oncology Centre of Central Municipal Clinical Hospital

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,

City

Zaporizhzhia

ZIP/Postal Code

69040

Country

Ukraine

Facility Name

State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",

City

Zaporizhzhya

ZIP/Postal Code

69040

Country

Ukraine

Facility Name

Kent Oncology Center

City

Maidstone

State/Province

Kent

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

Edinburgh Cancer Centre, Western General Hospital

City

Edinburgh

State/Province

Scotland

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Beatson Institute for Cancer Research

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Guys Hospital

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

The Royal Marsden NHS Foundation Trust

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Charing Cross Hospital

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Christie Hospital NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

The Research And Development Office, The Christie NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M204BX

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

35974168

Citation

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https://www.pmiform.com/clinical-trial-info-request?StudyID=A5481008

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

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