A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:February 12, 2008
End Date:November 23, 2018

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A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter
international clinical trial. Participants who have HER2-positive metastatic breast cancer
(MBC) and have not received chemotherapy or biological therapy (including approved or
investigational tyrosine kinase/HER inhibitors or vaccines) for their metastatic disease are
eligible for study. Participants could have received one prior hormonal treatment for MBC.
Participants may have received systemic breast cancer treatment in the neo-adjuvant or
adjuvant setting, provided that the participant has experienced a disease-free interval (DFI)
of greater than or equal to (>/=) 12 months from completion of adjuvant systemic treatment
(excluding hormonal therapy) to metastatic diagnosis. Participants may have received
trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.

Participants will be randomized in 1:1 ratio to receive pertuzumab or placebo along with
trastuzumab and docetaxel every 3 weeks (Q3W) in the treatment phase of the study until
investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or
study termination. Participants who were on placebo arm will be offered to receive after
completion of treatment phase but participants who discontinue from the study, will not
receive pertuzumab during open-label phase.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease, and candidate for chemotherapy. Participants with
measurable and non-measurable disease are eligible (locally recurrent disease must not
be amenable to resection with curative intent; participants with de novo Stage IV
disease are eligible)

- HER2-positive MBC

- Left ventricular ejection fraction (LVEF) >/=50 percent (%) at baseline (within 42
days of randomization)

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

- For women of childbearing potential, agreement to use an effective form of
contraception and to continue its use for the duration of study treatment and for 6
months after the last dose of study treatment

Exclusion Criteria:

- History of anti-cancer therapy for MBC (with the exception of one prior hormonal
regimen for MBC)

- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer
in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant
setting

- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting
with a disease-free interval from completion of the systemic treatment (excluding
hormonal therapy) to metastatic diagnosis of less than (<) 12 months

- History of persistent Grade >/=2 hematologic toxicity resulting from previous adjuvant
therapy

- Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria
for Adverse Events (NCI-CTCAE) Version 3.0, Grade >/=3 at randomization

- History of other malignancy within the last 5 years, except for carcinoma in situ of
the cervix or basal cell carcinoma

- Current clinical or radiographic evidence of central nervous system (CNS) metastases

- Computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain is
mandatory in cases of clinical suspicion of brain metastases

- History of exposure to cumulative doses of anthracyclines

- Current uncontrolled hypertension or unstable angina

- History of congestive heart failure (CHF) of any New York Heart Association (NYHA)
criteria, or serious cardiac arrhythmia requiring treatment

- History of myocardial infarction within 6 months of randomization

- History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or
adjuvant therapy

- Current dyspnea at rest due to complications of advanced malignancy, or other diseases
that require continuous oxygen therapy

- Inadequate organ function within 28 days prior to randomization

- Current severe, uncontrolled systemic disease

- Major surgical procedure or significant traumatic injury within 28 days prior to study
treatment start or anticipation of the need for major surgery during the course of
study treatment

- Pregnant or lactating women

- History of receiving any investigational treatment within 28 days of randomization

- Current known infection with human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C virus (HCV)

- Receipt of IV antibiotics for infection within 14 days of randomization

- Current chronic daily treatment with corticosteroids (excluding inhaled steroids)

- Known hypersensitivity to any of the study drugs

- Assessed by the investigator to be unable or unwilling to comply with the requirements
of the protocol
We found this trial at
274
sites
3840 Broadway
Fort Myers, Florida 33901
2203
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Fort Myers, FL
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Boca Raton, Florida 33428
2305
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Boca Raton, FL
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3700 Johnson Street
Hollywood, Florida 33021
2316
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Hollywood, FL
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3525
Lakeland, Florida 33805
2161
mi
from 91732
Lakeland, FL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
13
mi
from 91732
Los Angeles, CA
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
2320
mi
from 91732
Miami, FL
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
2303
mi
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Weston, FL
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6
mi
from 91732
Alhambra, CA
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Anaheim, California 92801
16
mi
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Anaheim, CA
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3460 East La Palma Avenue
Anaheim, California 92806
18
mi
from 91732
Anaheim, CA
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4671 Dallas Ranch Road
Antioch, California 94531
342
mi
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Antioch, CA
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340 Kennestone Hospital Boulevard
Austell, Georgia 30106
1907
mi
from 91732
Austell, GA
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Bakersfield, California 93309
105
mi
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Bakersfield, CA
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Baldwin Park, California 91706
3
mi
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Baldwin Park, CA
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Bellflower, California 90706
14
mi
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Bellflower, CA
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6420 Rockledge Drive
Bethesda, Maryland 20817
2275
mi
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Bethesda, MD
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Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
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Billings, Montana 59102
951
mi
from 91732
Billings, MT
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9776 Bonita Beach Road Southeast
Bonita Springs, Florida 34135
2215
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Bonita Springs, FL
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Boston, Massachusetts 02118
2577
mi
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Boston, MA
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650 Albany Street
Boston, Massachusetts 02118
2577
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Boston, MA
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2401 60th Street Court West
Bradenton, Florida 34209
2138
mi
from 91732
Bradenton, FL
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2401 60th Street Court West
Bradenton, Florida 34209
2138
mi
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Bradenton, FL
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403 South Kings Avenue
Brandon, Florida 33511
2146
mi
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Brandon, FL
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410 Stagecoach Road
Bristol, Virginia 24201
2018
mi
from 91732
Bristol, VA
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Brockport, New York 14420
2229
mi
from 91732
Brockport, NY
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1240 Francisco Acuña de Figueroa
Buenos Aires, C1180
6111
mi
from 91732
Buenos Aires,
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19
mi
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Burbank, CA
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Burnsville, Minnesota 55337
1504
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Burnsville, MN
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Campbell, California 95008
313
mi
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Campbell, CA
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Canandaigua, New York 14420
2261
mi
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Canandaigua, NY
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
2044
mi
from 91732
Canton, OH
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1708 Cape Coral Parkway West
Cape Coral, Florida 33914
2197
mi
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Cape Coral, FL
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1708 Cape Coral Parkway West
Cape Coral, Florida 33990
2197
mi
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Cape Coral, FL
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Carrollton, Georgia 30117
1882
mi
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Carrollton, GA
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100 Market Place Boulevard
Cartersville, Georgia 30121
1891
mi
from 91732
Cartersville, GA
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1501 West 7th Street
Chanute, Kansas 66720
1282
mi
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Chanute, KS
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975 East 3rd Street
Chattanooga, Tennessee 37403
1854
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Chattanooga, TN
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979 East 3rd Street
Chattanooga, Tennessee 37404
1854
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Chattanooga, TN
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Chattanooga, Tennessee 37404
1853
mi
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Chattanooga, TN
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
1887
mi
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Cincinnati, OH
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400 Pinellas Street
Clearwater, Florida 33756
2116
mi
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Clearwater, FL
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340 East Town Street
Columbus, Ohio 43215
1961
mi
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Columbus, OH
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1957
mi
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Columbus, OH
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
1964
mi
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Columbus, OH
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5141 West Broad Street
Columbus, Ohio 43228
1953
mi
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5141 West Broad Street
Columbus, Ohio 43228
1953
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27206 Calaroga Avenue
Concord, California 94520
335
mi
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Concord, CA
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Coon Rapids, Minnesota 55433
1510
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Coon Rapids, MN
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8170 Royal Palm Boulevard
Coral Springs, Florida 33065
2306
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Corona, California 92879
30
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Corona, CA
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Darby, Pennsylvania 19026
2370
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Darby, PA
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Deerfield, Illinois 60015
1719
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Deerfield, IL
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1190 East Newport Center Drive
Deerfield Beach, Florida 33442
2311
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2020 Central Avenue
Dodge City, Kansas 67801
1037
mi
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Dodge City, KS
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116 West Ross Boulevard
Dodge City, Kansas 67801
1037
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6002 Professional Parkway
Douglasville, Georgia 30134
1900
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Dover, Ohio 44622
2041
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Dover, OH
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Drexel Hill, Pennsylvania 19026
2368
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Drexel Hill, PA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2203
mi
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Durham, NC
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11480 Brookshire Avenue
Dwoney, California 90241
11
mi
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Dwoney, CA
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6401 France Avenue South
Edina, Minnesota 55435
1504
mi
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Edina, MN
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720 West Central Avenue
El Dorado, Kansas 67042
1208
mi
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El Dorado, KS
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Elmhurst, Illinois 60126
1714
mi
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Elmhurst, IL
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714 Doctors Drive
Englewood, Florida 34223
2168
mi
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Englewood, FL
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Farmington, New Mexico 87401
580
mi
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Farmington, NM
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34509 9th Avenue South
Federal Way, Washington 98003
940
mi
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Federal Way, WA
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Fontana, California 92335
31
mi
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Fontana, CA
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15681 New Hampshire Court
Fort Myers, Florida 33901
2204
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Fort Myers, FL
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Fort Myers, Florida 33905
2203
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Fort Myers, FL
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2202
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Fort Myers, FL
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Fountain Valley, California 92708
25
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Fountain Valley, CA
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Fountain Valley, California 92708
25
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Fountain Valley, CA
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Franklin, Tennessee 37067
1765
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Franklin, TN
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1823
mi
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Free Soil, MI
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480 Osborne Road Northeast
Fridley, Minnesota 55432
1513
mi
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Fridley, MN
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2151 North Harbor Boulevard
Fullerton, California 92835
13
mi
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Fullerton, CA
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6400 West Newberry Road
Gainesville, Florida 32605
2100
mi
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Gainesville, FL
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Gainesville, Georgia 30501
1945
mi
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Gainesville, GA
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1944
mi
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Gainesville, GA
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225 Big Station Camp Boulevard
Gallatin, Tennessee 37066
1781
mi
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Gallatin, TN
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789 Pre Emption Road
Geneva, New York 14456
2275
mi
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Geneva, NY
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Germantown, Tennessee 38138
1600
mi
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Germantown, TN
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Glendora, California 91741
9
mi
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Glendora, CA
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1843
mi
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Grand Rapids, MI
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250 Cherry Street Southeast
Grand Rapids, Michigan 49503
1840
mi
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Grand Rapids, MI
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5800 Foremost Drive Southeast
Grand Rapids, Michigan 49546
1846
mi
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Grand Rapids, MI
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2000 Newark Granville Road
Granville, Ohio 43023
1988
mi
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Granville, OH
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Hayward, California 94545
337
mi
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Hayward, CA
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Hermitage, Tennessee 37076
1773
mi
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Hermitage, TN
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2406 Century Place Southeast
Hickory, North Carolina 28602
2071
mi
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Hickory, NC
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999 W Ridge Rd
Hobart, Indiana 46342
1745
mi
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Hobart, IN
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1500 South Lake Park Avenue
Hobart, Indiana 46342
1745
mi
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Hobart, IN
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12460 Riley Street
Holland, Michigan 49424
1817
mi
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Holland, MI
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3501 Johnson Street
Hollywood, Florida 33021
2316
mi
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Hollywood, FL
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Hollywood, Florida 33021
2315
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Hollywood, FL
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Houston, Texas 77004
1339
mi
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Houston, TX
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741 East 19th Street
Houston, Texas 77008
1355
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Houston, TX
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Houston, Texas 77008
1358
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Houston, TX
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909 Frostwood Drive
Houston, Texas 77024
1347
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Houston, TX
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Houston, Texas 77203
1352
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Houston, TX
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