Clinical trial NCT00038467: Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
Official title: Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: International Collaborative Cancer Group
First posted: 2002-06-03
Enrollment: 4740
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

* unresectable breast cancer
* ER negative primary tumor

Primary outcomes:
measure: Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study
timeFrame: Baseline up to Month 36
Secondary outcomes:
measure: Overall Survival (OS) at Month 36 Post-Randomization: Main Study
timeFrame: Baseline up to Month 120
measure: Number of Events of Second Breast Cancer in Contralateral Breast: Main Study
timeFrame: Baseline up to Month 120
measure: Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
timeFrame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
measure: Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
timeFrame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
measure: Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study
timeFrame: Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment
measure: Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
measure: Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
measure: Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
measure: Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
measure: Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment
measure: Number of Participants With Fracture: Bone Metabolism Sub-study
timeFrame: Baseline up to 24 months post-treatment
measure: Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Functional Assessment of Cancer Therapy - Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Total Functional Assessment of Cancer Therapy - General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study
timeFrame: Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization
measure: Number of Participants With Severe Endocrine Symptoms: QoL Sub-study
timeFrame: Baseline up to 24 months after randomization
measure: Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study
timeFrame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
measure: Endometrial Thickness: Endometrial Sub-study
timeFrame: Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
measure: Uterine and Overall Ovary Volume: Endometrial Sub-study
timeFrame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
measure: Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study
timeFrame: 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment
measure: Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study
timeFrame: Baseline up to 24 months post-treatment
measure: Number of Participants With Histological Findings: Endometrial Sub-study
timeFrame: Baseline up to 24 months post-treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Green Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Green Velley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Thornton
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Jacksonville Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fishers
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Latham
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bedford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Garland
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Longview
country: United States
facility: Pfizer Investigational Site
state: Texas
city: McAllen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Odessa
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sherman
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tyler
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Weslaco
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Haedo
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: San Martin
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Rosario 2000
country: Argentina
facility: Pfizer Investigational Site
state: Pcia. de Santa Fe
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Dubbo
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Waratah
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Bendigo
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Box Hill
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Arlon
country: Belgium
facility: Pfizer Investigational Site
city: Baudour
country: Belgium
facility: Pfizer Investigational Site
city: Brasschaat
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Haine St. Paul
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Kraainem
country: Belgium
facility: Pfizer Investigational Site
city: La Louviere
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Merksem
country: Belgium
facility: Pfizer Investigational Site
city: Namur
country: Belgium
facility: Pfizer Investigational Site
city: Verviers
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Sarajevo
country: Bosnia and Herzegovina
facility: Pfizer Investigational Site
city: Plovdiv
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Osijek
country: Croatia
facility: Pfizer Investigational Site
city: Split
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: Prague 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Aarhus C
country: Denmark
facility: Pfizer Investigational Site
city: Esbjerg
country: Denmark
facility: Pfizer Investigational Site
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Herning
country: Denmark
facility: Pfizer Investigational Site
city: Hilleroed
country: Denmark
facility: Pfizer Investigational Site
city: Koebenhavn OE
country: Denmark
facility: Pfizer Investigational Site
city: Naestved
country: Denmark
facility: Pfizer Investigational Site
city: Roskilde
country: Denmark
facility: Pfizer Investigational Site
city: Vejle
country: Denmark
facility: Pfizer Investigational Site
city: Viborg
country: Denmark
facility: Pfizer Investigational Site
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Angers
country: France
facility: Pfizer Investigational Site
city: Annecy Cedex
country: France
facility: Pfizer Investigational Site
city: Avignon Cedex 2
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Bordeaux
country: France
facility: Pfizer Investigational Site
city: Brest
country: France
facility: Pfizer Investigational Site
city: Caen Cedex 05
country: France
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Evreux
country: France
facility: Pfizer Investigational Site
city: Lagny Sur Marne
country: France
facility: Pfizer Investigational Site
city: Le Havre
country: France
facility: Pfizer Investigational Site
city: Le Mans
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Lyon
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Meaux
country: France
facility: Pfizer Investigational Site
city: Montbeliard
country: France
facility: Pfizer Investigational Site
city: Mulhouse
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Perpignan
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: Saint-Herblain
country: France
facility: Pfizer Investigational Site
city: St Cloud
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Gera
country: Germany
facility: Pfizer Investigational Site
city: Greiz
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hildburghausen
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Luebeck
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Riesa
country: Germany
facility: Pfizer Investigational Site
city: Rodewisch
country: Germany
facility: Pfizer Investigational Site
city: Saarbruecken
country: Germany
facility: Pfizer Investigational Site
city: Suhl
country: Germany
facility: Pfizer Investigational Site
city: Weiden
country: Germany
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Attiki
city: Athens
country: Greece
facility: Pfizer Investigational Site
state: Attiki
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: New Territories
country: Hong Kong
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Cork, Ireland
country: Ireland
facility: Pfizer Investigational Site
city: Cork
country: Ireland
facility: Pfizer Investigational Site
city: Dublin 9
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Galway
country: Ireland
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Kfar Saba
country: Israel
facility: Pfizer Investigational Site
city: Petah Tikva
country: Israel
facility: Pfizer Investigational Site
city: Rehovot
country: Israel
facility: Pfizer Investigational Site
city: Carpi
country: Italy
facility: Pfizer Investigational Site
state: Modena
city: Alba (CN)
country: Italy
facility: Pfizer Investigational Site
city: Aviano (PN)
country: Italy
facility: Pfizer Investigational Site
city: Bergamo
country: Italy
facility: Pfizer Investigational Site
city: Biella
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Casale Monferrato, AL
country: Italy
facility: Pfizer Investigational Site
city: Correggio
country: Italy
facility: Pfizer Investigational Site
city: Cremona
country: Italy
facility: Pfizer Investigational Site
city: Cuneo
country: Italy
facility: Pfizer Investigational Site
city: Fermo FM
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Lecco
country: Italy
facility: Pfizer Investigational Site
city: Lodi
country: Italy
facility: Pfizer Investigational Site
city: Mantova
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Monserrato (CA)
country: Italy
facility: Pfizer Investigational Site
city: Monza
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Parma
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Piacenza
country: Italy
facility: Pfizer Investigational Site
city: Pietra Ligure (SV)
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Terni
country: Italy
facility: Pfizer Investigational Site
city: Thiene (VI)
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Tortona
country: Italy
facility: Pfizer Investigational Site
city: Trescore Balneario BG
country: Italy
facility: Pfizer Investigational Site
city: Treviglio (BG)
country: Italy
facility: Pfizer Investigational Site
city: Varese
country: Italy
facility: Pfizer Investigational Site
city: Luxembourg
country: Luxembourg
facility: Pfizer Investigational Site
city: Floriana
country: Malta
facility: Pfizer Investigational Site
city: Amersfoort
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Apeldoorn
country: Netherlands
facility: Pfizer Investigational Site
city: Blaricum
country: Netherlands
facility: Pfizer Investigational Site
city: Breda
country: Netherlands
facility: Pfizer Investigational Site
city: Delft
country: Netherlands
facility: Pfizer Investigational Site
city: Den Haag
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Groningen
country: Netherlands
facility: Pfizer Investigational Site
city: Hengelo
country: Netherlands
facility: Pfizer Investigational Site
city: Leeuwarden
country: Netherlands
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Leidschendam
country: Netherlands
facility: Pfizer Investigational Site
city: Podybus 90153
country: Netherlands
facility: Pfizer Investigational Site
city: Roermond
country: Netherlands
facility: Pfizer Investigational Site
city: Sittard
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Veldhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Zaandam
country: Netherlands
facility: Pfizer Investigational Site
city: Hamilton
country: New Zealand
facility: Pfizer Investigational Site
state: Waikato
city: Auckland
country: New Zealand
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Bodo
country: Norway
facility: Pfizer Investigational Site
city: Fredrikstad
country: Norway
facility: Pfizer Investigational Site
city: Haugesund
country: Norway
facility: Pfizer Investigational Site
city: Levanger
country: Norway
facility: Pfizer Investigational Site
city: Mo i Rana
country: Norway
facility: Pfizer Investigational Site
city: Molde
country: Norway
facility: Pfizer Investigational Site
city: Notodden
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Rissa
country: Norway
facility: Pfizer Investigational Site
city: Rjukan
country: Norway
facility: Pfizer Investigational Site
city: Sandefjord
country: Norway
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Tromso
country: Norway
facility: Pfizer Investigational Site
city: Tromsø
country: Norway
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Gliwice
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Opole
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Evora
country: Portugal
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Cluj Napoca
country: Romania
facility: Pfizer Investigational Site
city: Timisoara
country: Romania
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Sremska Kamenica
country: Serbia
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Observatory
country: South Africa
facility: Pfizer Investigational Site
city: Alcoy
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: San Juan de Alicante
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Sant Joan D'Alacant
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Terrassa
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Terrassa
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: San Sebastian
country: Spain
facility: Pfizer Investigational Site
state: Guipuzcoa
city: Barbastro
country: Spain
facility: Pfizer Investigational Site
state: Huesca
city: Reus
country: Spain
facility: Pfizer Investigational Site
state: Tarragona
city: Albacete
country: Spain
facility: Pfizer Investigational Site
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Badajoz
country: Spain
facility: Pfizer Investigational Site
city: Badajoz
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Lleida
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Borås
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Halmstad
country: Sweden
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Kristianstad
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Motala
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Nässjö
country: Sweden
facility: Pfizer Investigational Site
city: Varnamo
country: Sweden
facility: Pfizer Investigational Site
city: Vasteras
country: Sweden
facility: Pfizer Investigational Site
city: Vastervik
country: Sweden
facility: Pfizer Investigational Site
city: Vaxjo
country: Sweden
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Bellinzona
country: Switzerland
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Bern
country: Switzerland
facility: Pfizer Investigational Site
city: Genève
country: Switzerland
facility: Pfizer Investigational Site
city: Huntingdon
country: United Kingdom
facility: Pfizer Investigational Site
state: Cambs
city: Bournemouth
country: United Kingdom
facility: Pfizer Investigational Site
state: Dorset
city: Hull
country: United Kingdom
facility: Pfizer Investigational Site
state: East Yorkshire
city: Epping
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Westcliff-On-Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: Essex
city: Newport
country: United Kingdom
facility: Pfizer Investigational Site
state: Gwent
city: Bangor
country: United Kingdom
facility: Pfizer Investigational Site
state: Gwynedd
city: Salterhebble
country: United Kingdom
facility: Pfizer Investigational Site
state: Halifax
city: Gosport
country: United Kingdom
facility: Pfizer Investigational Site
state: Hants
city: Northwood
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Londonderry
country: United Kingdom
facility: Pfizer Investigational Site
state: N. Ireland
city: Harrogate
country: United Kingdom
facility: Pfizer Investigational Site
state: N. Yorkshire
city: Taunton
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Swansea
country: United Kingdom
facility: Pfizer Investigational Site
state: South Wales
city: York
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
city: Bradford
country: United Kingdom
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
city: Coventry
country: United Kingdom
facility: Pfizer Investigational Site
city: East Kilbride
country: United Kingdom
facility: Pfizer Investigational Site
city: Huddersfield
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Lincoln
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Luton
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Shrewsbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Somerset
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
city: Steeton
country: United Kingdom
facility: Pfizer Investigational Site
city: Stoke on Trent
country: United Kingdom
facility: Pfizer Investigational Site
city: Telford
country: United Kingdom
facility: Pfizer Investigational Site
city: Wythenshawe, Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: