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
4700 East Hale Parkway
Denver, Colorado 80220
1023
mi
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Denver, CO
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2485
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...
2402
mi
from 98109
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...
2329
mi
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Chapel Hill, NC
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3700 Johnson Street
Hollywood, Florida 33021
2720
mi
from 98109
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...
1556
mi
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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...
1814
mi
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Kalamazoo, MI
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3525
Lakeland, Florida 33805
2542
mi
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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...
962
mi
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Los Angeles, CA
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433 Southwest 10th Street
Ocala, Florida 34471
2483
mi
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Ocala, FL
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
2654
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,...
2486
mi
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Providence, RI
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Akron, Ohio 44304
2042
mi
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Akron, OH
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Albany, Georgia 31701
2283
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Albany, GA
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Albany, New York 12206
2351
mi
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Albany, NY
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Atlanta, Georgia 30341
2177
mi
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Atlanta, GA
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9103 Franklin Square Drive
Baltimore, Maryland 21237
2332
mi
from 98109
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...
2327
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...
2328
mi
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Baltimore, MD
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Basking Ridge, New Jersey 07920
2377
mi
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Basking Ridge, NJ
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6420 Rockledge Drive
Bethesda, Maryland 20817
2313
mi
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Bethesda, MD
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90 Poly Drive
Billings, Montana 59101
666
mi
from 98109
Billings, MT
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Boston, Massachusetts 02118
2485
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Boston, MA
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2485
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Boston, MA
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330 Brookline Avenue
Boston, Massachusetts 02215
2484
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Boston, MA
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450 Brookline Avenue
Boston, Massachusetts 02215
2483
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Boston, MA
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Brewer, Maine 04412
2517
mi
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Brewer, ME
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410 Stagecoach Road
Bristol, Virginia 24201
2167
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
2110
mi
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Buffalo, NY
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Charleston, South Carolina
2423
mi
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Charleston, SC
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Charleston, South Carolina 29403
2422
mi
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Charleston, SC
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Chattanooga, Tennessee 37404
2085
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...
1730
mi
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Chicago, IL
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5801 South Ellis Avenue
Chicago, Illinois 60637
1737
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...
1969
mi
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Cincinnati, OH
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1 Hospital Drive
Columbia, Missouri 65203
1612
mi
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Columbia, MO
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Columbia, South Carolina 29210
2322
mi
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Columbia, SC
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
2010
mi
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Columbus, OH
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Commack, New York 11725
2431
mi
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Commack, NY
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1680
mi
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Dallas, TX
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1678
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Dallas, TX
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1681
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...
1682
mi
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Dallas, TX
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Dayton, Ohio 45429
1964
mi
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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...
1734
mi
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Decatur, IL
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Edina, Minnesota 55432
1389
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Edina, MN
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1376
mi
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El Paso, TX
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1700 13th Street
Everett, California 98208
26
mi
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Everett, CA
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Fargo, North Dakota 58122
1172
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Fargo, ND
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3840 Broadway
Fort Myers, Florida 33901
2617
mi
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Fort Myers, FL
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Fort Worth, Texas 76104
1660
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Fort Worth, TX
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1662
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Fort Worth, TX
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Garland, Texas
1680
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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....
1794
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Grand Rapids, MI
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Green Bay, Wisconsin 54303
1642
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Green Bay, WI
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Green Bay, Wisconsin 54301
1645
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Green Bay, WI
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Greenbrae, California 94904
669
mi
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Greenbrae, CA
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65 International Drive
Greenville, South Carolina 29615
2228
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...
1739
mi
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Harvey, IL
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Hayward, California 94545
688
mi
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Hayward, CA
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2406 Century Place Southeast
Hickory, North Carolina 28602
2241
mi
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Hickory, NC
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1 Baylor Plaza
Hoston, Texas 77096
1892
mi
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Hoston, TX
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925 Gessner Road
Houston, Texas 77024
1882
mi
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Houston, TX
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1504 Ben Taub Loop
Houston, Texas 77030
1892
mi
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Houston, TX
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Irving, Texas 75063
1667
mi
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Irving, TX
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2021 North MacArthur Boulevard
Irving, Texas 75063
1671
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Irving, TX
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Jackson, Mississippi 39202
1983
mi
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Jackson, MS
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Jacksonville, Florida 32216
2457
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Jacksonville, FL
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
2459
mi
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Jacksonville, FL
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Jonesboro, Arkansas 72401
1806
mi
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Jonesboro, AR
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6420 Rockledge Drive
Kensington, Maryland 20895
2313
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Kensington, MD
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4485 West Stone Drive
Kingsport, Tennessee 37660
2147
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Kingsport, TN
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La Jolla, California 92093
1049
mi
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La Jolla, CA
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2004
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...
2392
mi
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Lebanon, NH
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Lincoln, Nebraska 68510
1346
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...
2386
mi
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Livingston, NJ
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Manchester, New Hampshire 03104
2447
mi
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Manchester, NH
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
2162
mi
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Marietta, GA
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Marshfield, Wisconsin 54449
1542
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...
1724
mi
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Maywood, IL
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910 East 26th Street
Minneapolis, Minnesota 55404
1392
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...
2160
mi
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Morgantown, WV
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120 Spalding Drive
Naperville, Illinois 60540
1712
mi
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Naperville, IL
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Nashville, Tennessee 37203
1970
mi
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Nashville, TN
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1973
mi
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Nashville, TN
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1448 Common Street
New Braunfels, Texas 78130
1786
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...
2402
mi
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New York, NY
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New York, New York 10003
2262
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New York, NY
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2262
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New York, NY
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New York, New York 10025
2444
mi
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New York, NY
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330 Washington Street
Norwich, Connecticut 06360
2463
mi
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Norwich, CT
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Oakland, California 94611
677
mi
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Oakland, CA
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675
mi
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Ogden, UT
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Omaha, Nebraska 68106
1367
mi
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Omaha, NE
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2751 Bay Park Drive
Oregon, Ohio 43616
1934
mi
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Oregon, OH
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603 North Flamingo Road
Pembroke Pines, Florida 33028
2715
mi
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Pembroke Pines, FL
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Peoria, Illinois 61656
1670
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...
2371
mi
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Philadelphia, PA
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5501 Old York Road
Philadelphia, Pennsylvania 19141
2371
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Philadelphia, PA
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