Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

Last updated: July 29, 2020
Sponsor: Bayer
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02258464
16298
2014-002113-39
  • Ages > 18
  • Female

Study Summary

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documentation of histological or cytological confirmation of estrogen receptorpositive (ER+) and HER2 negative adenocarcinoma of the breast must be available.

  • Women (≥18 years of age) with metastatic breast cancer not amenable to curativetreatment by surgery or radiotherapy.

  • Documentation of menopausal status: post menopausal or premenopausal subjects areeligible.

  • Subjects with bone dominant disease with at least 2 skeletal metastases identified atbaseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI).Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymphnodes)and/or visceral metastases is allowed.

  • Measurable or non-measurable disease (but radiologically evaluable) according toResponse Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

  • Subjects must have received at least one line of hormonal therapy in the metastaticsetting

  • Subjects who are eligible for further standard of care endocrine treatment.

  • Subjects enrolled in the current study must start treatment with the single hormoneagent either within 15 days prior to randomization or after randomization (before orsimultaneously to the first injection of Ra-223/placebo).

  • Subjects must have experienced no more than two skeletal-related events (SREs) priorto study entry defined as: Need for external beam radiotherapy (EBRT) tor bone,pathological bone fracture (excluding major trauma), spinal cord compression and/ororthopedic surgical procedure. Subjects with no prior SREs are not permitted.

  • Subjects must be on therapy with bisphosphonate and denosumab. and are required tohave been on such therapy for at least 1 month before start of study treatment.

  • Adequate hematological, liver and kidney function.

Exclusion

Exclusion Criteria:

  • Subjects with Inflammatory breast cancer.

  • Subjects who have either received chemotherapy for metastatic disease or areconsidered by the treating investigator to be appropriate candidates for chemotherapyas current treatment for metastatic breast cancer are excluded. Chemotherapyadministered for adjuvant/neo adjuvant disease is acceptable.

  • Subjects with known or history of brain metastases or leptomeningeal disease: subjectswith neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of thecentral nervous system (CNS) is otherwise not required.

  • Known presence of osteonecrosis of jaw.

  • Patients with immediately life-threatening visceral disease, for whom chemotherapy isthe preferred treatment option.

  • Lymphangitic carcinomatosis.

  • Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.

Study Design

Total Participants: 99
Study Start date:
March 02, 2015
Estimated Completion Date:
August 13, 2019

Connect with a study center

  • Linz, Oberösterreich 4020
    Austria

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    Leoben, Steiermark 8700
    Austria

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  • Innsbruck, 6020
    Austria

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  • Winnipeg, Manitoba R3E 0V9
    Canada

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  • London, Ontario N6A 4L6
    Canada

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  • Newmarket, Ontario L3Y 2P9
    Canada

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    Ottawa, Ontario K1H 8L6
    Canada

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  • Toronto, Ontario M5G 2M9
    Canada

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    Montreal, Quebec H3T 1E2
    Canada

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    Guangzhou, Guangdong 510080
    China

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    Beijing, 100032
    China

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    Shanghai,
    China

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    Chomutov, 430 12
    Czech Republic

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    Olomouc, 775 20
    Czech Republic

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  • Ostrava, 708 52
    Czechia

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  • Praha 2, 12808
    Czechia

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  • Copenhagen, 2100
    Denmark

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  • Herlev, 2730
    Denmark

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    Odense C, 5000
    Denmark

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    HUS, 00029
    Finland

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  • Helsinki, 00290
    Finland

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  • Tampere, FIN-33520
    Finland

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    Turku, FIN-20521
    Finland

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    Vaasa, 65130
    Finland

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  • Angers Cedex, 49055
    France

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    BRON cedex, 69677
    France

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    Bron, 69677
    France

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    Caen Cedex 5, 14076
    France

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    Clermont Ferrand Cedex 1, 63011
    France

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    Dijon, 21000
    France

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    Douai, 59500
    France

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    Grenoble, 38043
    France

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    La Roche Sur Yon Cedex, 85025
    France

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    Lille Cedex, 59020
    France

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    Montpellier Cedex, 34298
    France

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    Rennes Cedex, 35062
    France

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  • Saint Cloud, 92210
    France

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    Vandoeuvre Les Nancy, 54000
    France

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  • Tübingen, Baden-Württemberg 72076
    Germany

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    München, Bayern 81675
    Germany

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    Aachen, Nordrhein-Westfalen 52074
    Germany

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  • Bonn, Nordrhein-Westfalen 53105
    Germany

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  • Essen, Nordrhein-Westfalen 45147
    Germany

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    Köln, Nordrhein-Westfalen 50935
    Germany

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    Mainz, Rheinland-Pfalz 55131
    Germany

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    Shatin, New Territories
    Hong Kong

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    Hong Kong,
    Hong Kong

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  • Kowloon,
    Hong Kong

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    New Territories,
    Hong Kong

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  • Cork,
    Ireland

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    Ireland

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    Dublin 6,
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    Galway,
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  • Afula, 1834111
    Israel

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    Beer Sheva, 8410101
    Israel

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  • Haifa, 3109601
    Israel

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    Holon, 58100
    Israel

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  • Jerusalem, 9112001
    Israel

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  • Kfar Saba, 4428164
    Israel

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    Petach Tikva, 4941492
    Israel

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    Petah Tikva, 4941492
    Israel

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  • Ramat Gan, 5262000
    Israel

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    Rehovot, 7610001
    Israel

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  • Tel Aviv, 64239
    Israel

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    Tel Hashomer, 5262000
    Israel

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  • Zerifin, 7030000
    Israel

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    Forlì, Emilia-Romagna 47014
    Italy

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    Forlì-Cesena, Emilia-Romagna 47014
    Italy

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    Meldola, Forlì 47014
    Italy

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    Monza-Brianza, Lombardia 20900
    Italy

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    Verona, Veneto 37024
    Italy

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    Negrar, Verona 37024
    Italy

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    Bari, 70124
    Italy

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    Bologna, 40138
    Italy

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    Genova, 16128
    Italy

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    Milano, 20133
    Italy

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    Modena, 41124
    Italy

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    Monza, 20052
    Italy

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    Padova, 35128
    Italy

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    Palermo, 90146
    Italy

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    Pisa, 56126
    Italy

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    Reggio Emilia, 42100
    Italy

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    Roma, 00189
    Italy

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    Suwon-si, Gyeonggido 442-723
    Korea, Republic of

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  • Busan, 49241
    Korea, Republic of

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  • Daegu, 42601
    Korea, Republic of

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  • Incheon,
    Korea, Republic of

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  • Seoul, 03080
    Korea, Republic of

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    Amersfoort, 3818 TZ
    Netherlands

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    Den Haag, 2545 CH
    Netherlands

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    Dordrecht, 3318 AT
    Netherlands

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    Haarlem, 2035 RC
    Netherlands

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    Heerlen, 6401 CX
    Netherlands

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    Hoofddorp, 2134 TM
    Netherlands

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    Maastricht, 6229 HX
    Netherlands

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  • Nieuwegein, 3435 CM
    Netherlands

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    Nijmegen, 6500 HB
    Netherlands

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  • Zwolle, 8025 AB
    Netherlands

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    Bodø, 8092
    Norway

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  • Oslo, 0424
    Norway

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  • Bialystok, 15-027
    Poland

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    Gdansk, 80-952
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  • Gdynia, 81-519
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    Gliwice, 44-101
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    Krakow, 31-051
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    Lublin, 20-090
    Poland

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  • Warszawa, 02-781
    Poland

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  • Singapore, 119074
    Singapore

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  • L'Hospitalet de Llobregat, Barcelona 08907
    Spain

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    Palma de Mallorca, Illes Baleares
    Spain

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  • A Coruña, 15009
    Spain

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  • Barcelona, 08036
    Spain

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    Lugo, 27003
    Spain

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  • Madrid, 28033
    Spain

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  • Málaga, 29010
    Spain

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    Pamplona, 31008
    Spain

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    Salamanca, 37007
    Spain

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  • Sevilla, 41071
    Spain

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  • Zaragoza, 50009
    Spain

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    Göteborg, 413 45
    Sweden

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    Växjö, 35185
    Sweden

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  • Aarau, Aargau 5001
    Switzerland

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    Viganello, Ticino 6962
    Switzerland

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    Kaoshiung, 81346
    Taiwan

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    Taichung, 40705
    Taiwan

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  • Taipei, 11217
    Taiwan

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    Taiwan,
    Taiwan

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    Taoyuan, 333
    Taiwan

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  • Plymouth, Devon PL6 8DH
    United Kingdom

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    Romford, Essex RM7 0AG
    United Kingdom

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    Birkenhead, Merseyside CH63 4JY
    United Kingdom

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  • Northwood, Middlesex HA6 2RN
    United Kingdom

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  • Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

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  • Taunton, Somerset TA1 5DA
    United Kingdom

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    Guildford, Surrey GU27XX
    United Kingdom

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    Coventry, West Midlands CV2 2DX
    United Kingdom

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    Belfast, BT9 7AE
    United Kingdom

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    Bristol, BS2 8ED
    United Kingdom

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  • Cottingham, HU16 5JQ
    United Kingdom

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  • Merseyside, CH63 4JY
    United Kingdom

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  • Sheffield, S10 2SJ
    United Kingdom

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    Yuma, Arizona 85364
    United States

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  • Bakersfield, California 93309
    United States

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  • La Jolla, California 92093
    United States

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    Long Beach, California 90813
    United States

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  • Aurora, Colorado 80045
    United States

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  • New Haven, Connecticut 06520
    United States

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    Fort Lauderdale, Florida 33316
    United States

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    Ft. Lauderdale, Florida 33316
    United States

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    Plantation, Florida 33324
    United States

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  • Cedar Rapids, Iowa 52403
    United States

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    Ashland, Kentucky 41101
    United States

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  • Annapolis, Maryland 21401
    United States

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  • Ann Arbor, Michigan 48109
    United States

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    Detroit, Michigan 48202
    United States

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  • Pontiac, Michigan 48341
    United States

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    Rochester, Minnesota 55905
    United States

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  • Saint Louis, Missouri 63110
    United States

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    St. Louis, Missouri 63110
    United States

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    Omaha, Nebraska 68130
    United States

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    Newark, New Jersey 07103
    United States

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    Lake Success, New York 11042
    United States

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    Bismarck, North Dakota 58501
    United States

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    Cleveland, Ohio 44195
    United States

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    Philadelphia, Pennsylvania 19104
    United States

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  • Pittsburgh, Pennsylvania 15213-3180
    United States

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    Watertown, South Dakota 57201
    United States

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  • Houston, Texas 77230
    United States

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    Spokane, Washington 99208
    United States

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