A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:November 8, 2011
End Date:December 1, 2023

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A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and
efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in
participants with operable HER2-positive primary breast cancer. This study will be carried
out in collaboration with the Breast International Group (BIG).


Inclusion Criteria:

- Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is
histologically confirmed, and adequately excised

- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(
- Known hormone receptor status (estrogen receptor and progesterone receptor)

- The interval between definitive surgery for breast cancer and the first dose of
chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy
must be administered within 7 days of randomization or on Day 56, whichever occurs
first

- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55
percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA)
Scan

- Confirmed HER2 positive status

- Completion of all necessary baseline laboratory and radiologic investigations prior to
randomization

- Women of childbearing potential and male participants with partners of childbearing
potential must agree to use effective contraception (as defined by the protocol) by
the participant and/or partner for the duration of the study treatment and for at
least 7 months after the last dose of study drug

Exclusion Criteria:

- History of any prior (ipsi- and/or contralateral) invasive breast cancer

- History of non-breast malignancies within the 5 years prior to study entry, except for
carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and
basal cell and squamous cell carcinomas of the skin

- Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant
metastasis (TNM), including inflammatory breast cancer

- Any node-negative tumor

- Any previous systemic chemotherapy for cancer or radiotherapy for cancer

- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy
for cancer

- Concurrent anti-cancer treatment in another investigational trial

- Serious cardiac or cardiovascular disease or condition

- Other concurrent serious diseases that may interfere with planned treatment including
severe pulmonary conditions/illness

- Abnormal laboratory tests immediately prior to randomization

- Pregnant or lactating women

- Sensitivity to any of the study medications or any of the ingredients or excipients of
these medications
We found this trial at
144
sites
Charleston, South Carolina
1063
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Charleston, SC
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
1293
mi
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Bronx, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
1038
mi
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Chapel Hill, NC
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3700 Johnson Street
Hollywood, Florida 33021
1310
mi
from
Hollywood, FL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
428
mi
from
Iowa City, IA
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
718
mi
from
Kalamazoo, MI
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3525
Lakeland, Florida 33805
1134
mi
from
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...
1168
mi
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Los Angeles, CA
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433 Southwest 10th Street
Ocala, Florida 34471
1078
mi
from
Ocala, FL
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
1247
mi
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Port Saint Lucie, FL
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
1424
mi
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Providence, RI
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Akron, Ohio 44304
899
mi
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Akron, OH
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Albany, Georgia 31701
884
mi
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Albany, GA
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Albany, New York 12206
1308
mi
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Albany, NY
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Atlanta, Georgia 30341
802
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Atlanta, GA
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9103 Franklin Square Drive
Baltimore, Maryland 21237
1155
mi
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Baltimore, MD
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
1148
mi
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Baltimore, MD
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
1149
mi
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Baltimore, MD
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Basking Ridge, New Jersey 07920
1258
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Basking Ridge, NJ
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6420 Rockledge Drive
Bethesda, Maryland 20817
1121
mi
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Bethesda, MD
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90 Poly Drive
Billings, Montana 59101
781
mi
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Billings, MT
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Boston, Massachusetts 02118
1443
mi
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Boston, MA
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1444
mi
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Boston, MA
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330 Brookline Avenue
Boston, Massachusetts 02215
1441
mi
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Boston, MA
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450 Brookline Avenue
Boston, Massachusetts 02215
1441
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Boston, MA
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Brewer, Maine 04412
1575
mi
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Brewer, ME
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410 Stagecoach Road
Bristol, Virginia 24201
866
mi
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Bristol, VA
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Buenos Aires,
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Buenos Aires,
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Buffalo, New York 14263
1056
mi
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Buffalo, NY
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Charleston, South Carolina 29403
1062
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Charleston, SC
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Chattanooga, Tennessee 37404
722
mi
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Chattanooga, TN
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
608
mi
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Chicago, IL
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5801 South Ellis Avenue
Chicago, Illinois 60637
609
mi
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Chicago, IL
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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...
734
mi
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Cincinnati, OH
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1 Hospital Drive
Columbia, Missouri 65203
308
mi
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Columbia, MO
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Columbia, South Carolina 29210
973
mi
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Columbia, SC
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
815
mi
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Columbus, OH
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Commack, New York 11725
1324
mi
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Commack, NY
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347
mi
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Dallas, TX
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342
mi
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Dallas, TX
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348
mi
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Dallas, TX
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
349
mi
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Dallas, TX
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Dayton, Ohio 45429
747
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Dayton, OH
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
499
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Decatur, IL
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4700 East Hale Parkway
Denver, Colorado 80220
406
mi
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Denver, CO
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Edina, Minnesota 55432
559
mi
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Edina, MN
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641
mi
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El Paso, TX
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1700 13th Street
Everett, California 98208
1414
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Everett, CA
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Fargo, North Dakota 58122
635
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Fargo, ND
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3840 Broadway
Fort Myers, Florida 33901
1206
mi
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Fort Myers, FL
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Fort Worth, Texas 76104
346
mi
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Fort Worth, TX
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348
mi
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Fort Worth, TX
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Garland, Texas
340
mi
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Garland, TX
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
(616) 391-1230
Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
733
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Grand Rapids, MI
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Green Bay, Wisconsin 54303
690
mi
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Green Bay, WI
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Green Bay, Wisconsin 54301
691
mi
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Green Bay, WI
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Greenbrae, California 94904
1343
mi
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Greenbrae, CA
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65 International Drive
Greenville, South Carolina 29615
885
mi
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Greenville, SC
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
601
mi
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Harvey, IL
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Hayward, California 94545
1322
mi
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Hayward, CA
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2406 Century Place Southeast
Hickory, North Carolina 28602
924
mi
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Hickory, NC
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1 Baylor Plaza
Hoston, Texas 77096
572
mi
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Hoston, TX
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925 Gessner Road
Houston, Texas 77024
565
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Houston, TX
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1504 Ben Taub Loop
Houston, Texas 77030
572
mi
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Houston, TX
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Irving, Texas 75063
338
mi
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Irving, TX
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2021 North MacArthur Boulevard
Irving, Texas 75063
343
mi
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Irving, TX
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Jackson, Mississippi 39202
572
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Jackson, MS
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Jacksonville, Florida 32216
1061
mi
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Jacksonville, FL
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
1062
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Jonesboro, Arkansas 72401
416
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Jonesboro, AR
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6420 Rockledge Drive
Kensington, Maryland 20895
1121
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4485 West Stone Drive
Kingsport, Tennessee 37660
839
mi
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La Jolla, California 92093
1118
mi
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La Jolla, CA
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617
mi
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Lafayette, LA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
1393
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Lebanon, NH
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Lincoln, Nebraska 68510
221
mi
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Lincoln, NE
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
1271
mi
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Livingston, NJ
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Manchester, New Hampshire 03104
1427
mi
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Manchester, NH
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
786
mi
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Marietta, GA
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Marshfield, Wisconsin 54449
621
mi
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Marshfield, WI
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
600
mi
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Maywood, IL
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910 East 26th Street
Minneapolis, Minnesota 55404
550
mi
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Minneapolis, MN
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
970
mi
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Morgantown, WV
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120 Spalding Drive
Naperville, Illinois 60540
583
mi
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Naperville, IL
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Nashville, Tennessee 37203
618
mi
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Nashville, TN
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620
mi
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Nashville, TN
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1448 Common Street
New Braunfels, Texas 78130
554
mi
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New Braunfels, TX
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
1289
mi
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New York, NY
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New York, New York 10003
1225
mi
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New York, NY
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1225
mi
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New York, NY
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New York, New York 10025
1341
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New York, NY
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330 Washington Street
Norwich, Connecticut 06360
1388
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Norwich, CT
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Oakland, California 94611
1327
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Oakland, CA
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790
mi
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Ogden, UT
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Omaha, Nebraska 68106
261
mi
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Omaha, NE
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2751 Bay Park Drive
Oregon, Ohio 43616
806
mi
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Oregon, OH
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603 North Flamingo Road
Pembroke Pines, Florida 33028
1304
mi
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Pembroke Pines, FL
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Peoria, Illinois 61656
480
mi
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Peoria, IL
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
1223
mi
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Philadelphia, PA
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5501 Old York Road
Philadelphia, Pennsylvania 19141
1226
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Philadelphia, PA
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