Phase
Condition
Breast Cancer
Cancer
Treatment
Lapatinib
Capecitabine
Trastuzumab emtansine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
HER2 status must be prospectively, centrally tested and be HER2-positive based oncentral laboratory assay results
Histologically or cytologically confirmed invasive breast cancer
Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, ormetastatic setting must include both a taxane, alone or in combination with anotheragent, and trastuzumab, alone or in combination with another agent
Documented progression (which occur during or after most recent treatment or within 6months after completing of adjuvant therapy) of incurable, unresectable, locallyadvanced or metastatic breast cancer, defined by the investigator
Measurable and/or nonmeasurable disease; participants with central nervous system-onlydisease are excluded
Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by eitherechocardiogram or multi-gated acquisition scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
For women of childbearing potential and men with partners of childbearing potential,agreement to use a highly effective, non-hormonal form of contraception; contraceptionuse should continue for the duration of the study treatment and for at least 6 monthsafter the last dose of study treatment
Exclusion
Exclusion Criteria:
History of treatment with trastuzumab emtansine
Prior treatment with lapatinib or capecitabine
Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common TerminologyCriteria for Adverse Events (NCI-CTCAE), Version 3.0
History of other malignancy within the last 5 years, except for appropriately treatedcarcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer,synchronous or previously diagnosed HER2-positive breast cancer, or cancers with asimilar curative outcome as those mentioned above
History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7days prior to randomization; recovery of treatment-related toxicity consistent withother eligibility criteria
History of radiation therapy within 14 days of randomization
Brain metastases that are untreated, symptomatic, or require therapy to controlsymptoms, as well as any history of radiation, surgery, or other therapy, includingsteroids, to control symptoms from brain metastases within 2 months (60 days) ofrandomization
History of symptomatic congestive heart failure or serious cardiac arrhythmiarequiring treatment
History of myocardial infarction or unstable angina within 6 months of randomization
Current dyspnea at rest due to complications of advanced malignancy or currentrequirement for continuous oxygen therapy
Current severe, uncontrolled systemic disease (for example, clinically significantcardiovascular, pulmonary, or metabolic disease)
Pregnancy or lactation
Current known active infection with human immunodeficiency virus (HIV), hepatitis Bvirus, or hepatitis C virus
Presence of conditions that could affect gastrointestinal absorption: Malabsorptionsyndrome, resection of the small bowel or stomach, and ulcerative colitis
History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab
Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenasedeficiency
Current treatment with sorivudine or its chemically related analogs, such as brivudine
Study Design
Connect with a study center
Banja Luka, 78000
Bosnia and HerzegovinaSite Not Available
Sarajewo, 71000
Bosnia and HerzegovinaSite Not Available
Belo Horizonte, 30150-281
BrazilSite Not Available
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Belo Horizonte, Mg, 30150-281
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Curitiba, 80530-010
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Goiania, 74605-070
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Itajai, 88301-220
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ItajaÃ, 88301220
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Itajaí, 88301220
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JAU, 17210-080
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JAÚ, 17210-080
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JAÚ, 17210-120
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Joao Pessoa, 58040280
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Porto Alegre, 90430-090
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Porto Alegre - Rs, 90050-170
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Rio de Janeiro, 20560-120
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Santo Andre, 09060-870
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Sao Paulo, 01317-000
BrazilSite Not Available
Plovdiv, 4000
BulgariaSite Not Available
Sofia, 1756
BulgariaSite Not Available
Varna, 9002
BulgariaSite Not Available
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Edmonton, Alberta T6G 1Z2
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Kelowna, British Columbia V1Y 5L3
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Vancouver, British Columbia V5Z 1H5
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Halifax, Nova Scotia B3H 2Y9
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Ottawa, Ontario K1H 8L6
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Sudbury, Ontario J9P 3Y1
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Toronto, Ontario M4N 3M5
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Greenfield Park, Quebec J4V 2H1
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Montreal, Quebec H2W 1T8
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Bogota, 49 00
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Monteria,
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Copenhagen, 2100
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Herlev, 2730
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Hillerød, 3400
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Hillerød, 3400
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København, 2100
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København, 2100
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Odense, 5000
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Helsinki, 00180
FinlandSite Not Available
Tampere, 33520
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Turku, 20520
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Avignon, 84082
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Bordeaux, 33076
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Brest, 29609
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Caen, 14076
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Dijon, 21079
FranceSite Not Available
La Roche Sur Yon, 85925
FranceSite Not Available
Montpellier, 34298
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Paris, 75248
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Saint Brieuc, 22015
FranceSite Not Available
Saint Herblain, 44805
FranceSite Not Available
Vandoeuvre-les-nancy, 54511
FranceSite Not Available
Aschaffenburg, 63739
GermanySite Not Available
Berlin, 4169
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Berlin-lichtenberg, 10367
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Bonn, 53113
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Dortmund, 44137
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Freiburg, 79106
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Fuerstenwalde, 15517
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Fürstenwalde, 15517
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Fürstenwalde, 15517
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Hamburg, 20357
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Karlsruhe, 76135
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Karlsuhe, 76135
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Kiel, 24105
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Offenbach, 63069
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Stralsund, 18435
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Hong Kong,
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Tuen Mun,
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Bangalore, 560027
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Gurgaon, 122001
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Kolkata, 700 053
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New Delhi, 110029
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Pune, 411004
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Aviano, 33081
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Bologna, 40138
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Candiolo, 10060
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Genova, 16132
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Meldola, 47014
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Milano, 20141
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Napoli, 80131
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Negrar, 37024
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Pisa, 56100
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Reggio Emilia, 42100
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Roma, 00168
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Rozzano, 20089
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Sassari, 07100
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Terni, 05100
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Kyunggi-do, 411-769
Korea, Republic ofSite Not Available
Seoul, 135-710
Korea, Republic ofSite Not Available
Acapulco, 39670
MexicoSite Not Available
Oaxaca, 68000
MexicoSite Not Available
Toluca, 50180
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Newtown, 6021
New ZealandSite Not Available
Palmerston North, 4442
New ZealandSite Not Available
Diliman, Quezon City, 1100
PhilippinesSite Not Available
Quezon City, Luzon, 1101
PhilippinesSite Not Available
Bialystok, 15-027
PolandSite Not Available
Gdansk, 80-952
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Krakow, 31-531
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Lublin, 20-090
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Opole, 45-060
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Poznan, 61-866
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Warszawa, 02-781
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Coimbra, 3000-075
PortugalSite Not Available
Lisboa, 1649-035
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Porto, 4200-072
PortugalSite Not Available
Kemerovo, 650036
Russian FederationSite Not Available
Moscow, 121356
Russian FederationSite Not Available
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Persochnysaint-petersburg, 197758
Russian FederationSite Not Available
St Petersburg, 197758
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Singapore, 169610
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Ljubljana, 1000
SloveniaSite Not Available
Barcelona, 08035
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Córdoba, 14004
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Córdoba, 14004
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Lerida, 25198
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Lleida, 25198
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Madrid, 28041
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Santander, 39008
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Sevilla, 41013
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Valencia, 46009
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Zaragoza, 50009
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Eskilstuna, 63188
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Gaelve, 80187
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Goteborg, 40036
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Göteborg, 41345
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Göteborg, 41345
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Luzern, 6004
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St Gallen, 9007
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St. Gallen, 9007
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Kaohsiung, 833
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Kaohsung, 883
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Taichung, 404
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Taipei, 112
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Taoyuan, 333
TaiwanSite Not Available
Bournemouth, BH7 7DW
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Bristol, BS2 8ED
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Cardiff, CF14 2TL
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Denbigh, LL18 5UJ
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London, SW3 6JJ
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Manchester, M20 4BX
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New Castle Upon Tyne, NE7 7DN
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Newcastle Upon Tyne, NE7 7DN
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Northwood, HA6 2RN
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Poole, BH15 2JB
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Preston, PR2 9HT
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Romford, RM7 0AG
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Sutton, SM2 5PT
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Weston Super Mare, BS23 4TQ
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Chandler, Arizona 85224
United StatesSite Not Available
Tucson, Arizona 85719
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Anaheim, California 92807
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Bakersfield, California 93309
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Baldwin Park, California 91706
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Bellflower, California 90706
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Duarte, California 91010
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Fontana, California 92335
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Hayward, California 94545
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Irvine, California 92618
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La Jolla, California 92093
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La Mesa, California 91942
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Loma Linda, California 92354
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Long Beach, California 90806
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Los Angeles, California 90095-1772
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Montebello, California 90640
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Newport Beach, California 92660
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Oakland, California 94611
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Panorama City, California 91402
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Riverside, California 92505
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Roseville, California 95661
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Sacramento, California 95825
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San Diego, California 92120
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San Francisco, California 94115
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San Jose, California 95119
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Santa Clara, California 95051
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Santa Maria, California 93454
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Santa Monica, California 90404
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South San Francisco, California 94080
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Thousand Oaks, California 91360
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Vallejo, California 94589
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Walnut Creek, California 94596
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Woodland Hills, California 91367
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Fort Collins, Colorado 80528
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Norwalk, Connecticut 06856
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Norwich, Connecticut 06360
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Stamford, Connecticut 06902
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Boca Raton, Florida 33486
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Fernandina Beach, Florida 32034
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Fort Myers, Florida 33916
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Ft. Lauderdale, Florida 33316
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Hollywood, Florida 33021
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Jacksonville, Florida 32207
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Kissimmee, Florida 34741
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Lakeland, Florida 33804-1057
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Miami, Florida 33136
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Orange Park, Florida 32073
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Pembroke Pines, Florida 33028
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Athens, Georgia 30607
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Atlanta, Georgia 30322
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Carrolton, Georgia 30117
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Cartersville, Georgia 30121
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Decatur, Georgia 30033
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Douglasville, Georgia 30134
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Macon, Georgia 31217
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Marietta, Georgia 30060
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Boise, Idaho 83712
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Meridian, Idaho 83642
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Nampa, Idaho 83686
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Post Falls, Idaho 83854
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Twin Falls, Idaho 83301
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Chicago, Illinois 60612
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Effingham, Illinois 62526
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Joliet, Illinois 60435
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Morris, Illinois 60450
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Peoria, Illinois 61615-7828
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Skokie, Illinois 60076
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Zion, Illinois 60099
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Bettendorf, Iowa 52722
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Wichita, Kansas 67214-3728
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Paducah, Kentucky 42001
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Covington, Louisiana 70433
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Lafayette, Louisiana 70503
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Marrero, Louisiana 70072
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Metairie, Louisiana 70006
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New Orleans, Louisiana 70115
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Kittery, Maine 03904
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Wells, Maine 04090
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York, Maine 03909
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Baltimore, Maryland 21202
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Bethesda, Maryland 20817
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Rockville, Maryland 20850
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Boston, Massachusetts 02215
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Burlington, Massachusetts 01805
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Peabody, Massachusetts 01960
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Brownstown, Michigan 48183
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Dearborn, Michigan 48126
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Detroit, Michigan 48202
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Saint Joseph, Michigan 49085
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West Bloomfield, Michigan 48322
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Edina, Minnesota 55414
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Maplewood, Minnesota 55109
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Minneapolis, Minnesota 55454
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Saint Louis Park, Minnesota 55426
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Saint Paul, Minnesota 55101
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St. Louis Park, Minnesota 55426
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Joplin, Missouri 64804
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Kansas City, Missouri 64111
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Saint Louis, Missouri 63110
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Saint Peters, Missouri 63110
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St. Louis, Missouri 63141
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St. Peters, Missouri 63376
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Missoula, Montana 59802
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Omaha, Nebraska 68114
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Henderson, Nevada 89052
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Cherry Hill, New Jersey 08002
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Hackensack, New Jersey 07601
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Morristown, New Jersey 07962
United StatesSite Not Available
Parsippany, New Jersey 07054
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Voorhees, New Jersey 08043
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Santa Fe, New Mexico 87505
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Brockport, New York 14420
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Canandaigua, New York 14424
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Fresh Meadows, New York 11366
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Geneva, New York 14456
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Greece, New York 14626
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Lake Success, New York 11042
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Mount Kisco, New York 10549
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New Hyde Park, New York 11042
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Rochester, New York 14626
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Stony Brook, New York 11794
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Charlotte, North Carolina 28203
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Durham, North Carolina 27710
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Hickory, North Carolina 28602
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Kinston, North Carolina 28501
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Washington, North Carolina 27889
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Cleveland, Ohio 44195
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Columbus, Ohio 43219
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Granville, Ohio 43023
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Middletown, Ohio 45042
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Newark, Ohio 43055
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Sandusky, Ohio 44870
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Portland, Oregon 97227
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Philadelphia, Pennsylvania 19124
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Pittsburgh, Pennsylvania 15213
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East Providence, Rhode Island 02915
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Charleston, South Carolina 29425
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Columbia, South Carolina 29210
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North Charleston, South Carolina 29425
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Memphis, Tennessee 38120
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Nashville, Tennessee 37203
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Austin, Texas 78731
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Bryan, Texas 77802
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Cypress, Texas 77429
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Dallas, Texas 75230
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El Paso, Texas 79902
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Houston, Texas 77090
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Shenandoah, Texas 77384
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Temple, Texas 76501
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Fairfax, Virginia 22031
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Gig Harbor, Washington 98332
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Lakewood, Washington 98499
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Puyallup, Washington 98372
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Tacoma, Washington 98405
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Milwaukee, Wisconsin 53226
United StatesSite Not Available
Wausau, Wisconsin 54401
United StatesSite Not Available
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