A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:February 22, 2013
End Date:June 30, 2020

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Trial Summary
Trial Overview
Inclusion Criteria

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

The study is designed to compare the clinical benefit following treatment with letrozole in
combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal
women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti
cancer therapies for their advanced/metastatic disease.


Inclusion Criteria:

- Adult women with locoregionally recurrent or metastatic disease not amenable to
curative therapy.

- Confirmed diagnosis of ER positive breast cancer

- No prior systemic anti-cancer therapy for advanced ER+ disease.

- Postmenopausal women

- Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or
bone-only disease

- Eastern Cooperative Oncology Group [ECOG] 0-2

- Adequate organ and marrow function

- Patient must agree to provide tumor tissue

Exclusion Criteria:

- Confirmed diagnosis of HER2 positive disease

- Patients with advanced, symptomatic, visceral spread that are at risk of life
threatening complication in the short term

- Known uncontrolled or symptomatic CNS metastases

- Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from
completion of treatment.

- Prior treatment with any CDK 4/6 inhibitor.
We found this trial at
151
sites
Tennessee Oncology, PLLC
Lebanon, Tennessee 37087
644
mi
from
Lebanon, TN
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Memorial Cancer Institute at Memorial Regional Hospital
1150 N 35th Ave # 330
Hollywood, Florida 33021
1310
mi
from
Hollywood, FL
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Orlando Health
24 Sturtevant St
Orlando, Florida 32806
1142
mi
from
Orlando, FL
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
1383
mi
from
Portland, OR
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Central Coast Medical Oncology Corporation
220 S Palisade Dr # 204
Santa Maria, California 93454
1268
mi
from
Santa Maria, CA
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Seattle Cancer Care Alliance
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
1410
mi
from
Seattle, WA
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
808
mi
from
Ann Arbor, MI
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Emory University Hospital Midtown
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
801
mi
from
Atlanta, GA
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The Emory Clinic
Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
803
mi
from
Atlanta, GA
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Grady Health System
Atlanta, Georgia 30303
801
mi
from
Atlanta, GA
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Winship Cancer Institute
Atlanta, Georgia 30322
803
mi
from
Atlanta, GA
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Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin, Missouri 63011
399
mi
from
Ballwin, MO
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University of Maryland
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
from
Baltimore, MD
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Southern California Permanente Medical Group
BellFlower, California 90706
1165
mi
from
BellFlower, CA
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Walter Reed National Military Medical Center
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
1123
mi
from
Bethesda, MD
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Beverly Hills Cancer Center
Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
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Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
Blacksburg, Virginia 24060
1008
mi
from
Blacksburg, VA
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Mount Kisco Medical Group
Brewster, New York 10509
1308
mi
from
Brewster, NY
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The Mark M. Connolly Center for Cancer and Specialty Care
Chicago, Illinois 60657
609
mi
from
Chicago, IL
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Kootenai Clinic Cancer Services
Coeur d'Alene, Idaho 83814
1176
mi
from
Coeur d'Alene, ID
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The West Clinic
Corinth, Mississippi 38834
552
mi
from
Corinth, MS
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
347
mi
from
Dallas, TX
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Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas 75231
342
mi
from
Dallas, TX
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Carle Foundation Hospital DBA Carle Cancer Center
Danville, Illinois 61832
571
mi
from
Danville, IL
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St. Vincents Hospital Sydney
Darlinghurst, New South Wales 2010
8648
mi
from
Darlinghurst,
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Sylvester at Deerfield Beach
Deerfield Beach, Florida 33442
1298
mi
from
Deerfield Beach, FL
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Tennessee Oncology, PLLC
Dickson, Tennessee 37055
587
mi
from
Dickson, TN
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Carle Foundation Hospital DBA Carle Cancer Center
Effingham, Illinois 62401
510
mi
from
Effingham, IL
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Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas 79939
642
mi
from
El Paso, TX
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Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas 79902
641
mi
from
El Paso, TX
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Texas Oncology - El Paso Cancer Treatment Center Gateway
El Paso, Texas 79915
642
mi
from
El Paso, TX
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Presence Infusion Care- Evanston
Evanston, Illinois 60202
612
mi
from
Evanston, IL
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CUMC Herbert Irving Pavilion
Fort Lee, New Jersey 07024
?
mi
from
Fort Lee, NJ
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
348
mi
from
Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
348
mi
from
Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
348
mi
from
Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
348
mi
from
Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
348
mi
from
Fort Worth, TX
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Tennessee Oncology, PLLC
Franklin, Tennessee 37067
623
mi
from
Franklin, TN
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St. Joseph Heritage Healthcare
Fullerton, California 92835
1154
mi
from
Fullerton, CA
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Tennessee Oncology, PLLC
Gallatin, Tennessee 37066
633
mi
from
Gallatin, TN
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The West Clinic, PC dba West Cancer Centre
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
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Los Angeles Hematology Oncology Medical Group
Glendale, California 91206
1167
mi
from
Glendale, CA
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Saint Francis Medical Center
Grand Island, Nebraska 68803
220
mi
from
Grand Island, NE
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Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Grand Island, Nebraska 68803
210
mi
from
Grand Island, NE
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St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado 81501
587
mi
from
Grand Junction, CO
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Saint Francis Medical Center
Hastings, Nebraska 68901
198
mi
from
Hastings, NE
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
954
mi
from
Henderson, NV
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
954
mi
from
Henderson, NV
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Tennessee Oncology, PLLC
Hermitage, Tennessee 37076
629
mi
from
Hermitage, TN
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Memorial Regional Hospital
Hollywood, Florida 33021
1309
mi
from
Hollywood, FL
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Memorial Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida 33021
1310
mi
from
Hollywood, FL
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The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
Houston, Texas 77030
569
mi
from
Houston, TX
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University of Texas M.D. Anderson Cancer Center
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
572
mi
from
Houston, TX
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UCLA Hematology Oncology Irvine
Irvine, California 92604
1152
mi
from
Irvine, CA
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US Oncology Investigational Products Center
Irving, Texas 75063
337
mi
from
Irving, TX
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Cancer Specialist of North Florida, Pharmacy
Jacksonville, Florida 32256
1055
mi
from
Jacksonville, FL
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Cancer Specialists of North Florida-Southpoint
Jacksonville, Florida 32256
1055
mi
from
Jacksonville, FL
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UCLA Hematology Oncology- Laguna Hills
Laguna Hills, California 92653
1149
mi
from
Laguna Hills, CA
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
970
mi
from
Las Vegas, NV
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
970
mi
from
Las Vegas, NV
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
970
mi
from
Las Vegas, NV
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Comprehensive Cancer Centers of Nevada Research Department
3730 South Eastern Avenue
Las Vegas, Nevada 89119
960
mi
from
Las Vegas, NV
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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Ucla Hematology/Oncology
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
1177
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
1169
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy, Attn: Steven L. Wong
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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UCLA West Medical Pharmacy (Drug Management Only)
Los Angeles, California 90091
1164
mi
from
Los Angeles, CA
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Regulatory Management Only: TRIO-US Central Administration
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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TRIO-US Central Administration (Regulatory Management only)
Los Angeles, California 93309
1187
mi
from
Los Angeles, CA
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Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
Los Angeles, California 90095
1179
mi
from
Los Angeles, CA
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Translational Research Management
Los Angeles, California 90045
1168
mi
from
Los Angeles, CA
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Southern California Permanente Medical Group
Los Angeles, California 90027
1169
mi
from
Los Angeles, CA
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James Graham Brown Cancer Center and University Hospital
Louisville, Kentucky 40202
657
mi
from
Louisville, KY
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James Graham Brown Cancer Center
529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
657
mi
from
Louisville, KY
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Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Low Moor, Virginia 24457
978
mi
from
Low Moor, VA
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
574
mi
from
Madison, WI
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Northwest Georgia Oncology Centers, PC
Marietta, Georgia 30060
788
mi
from
Marietta, GA
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Carle Foundation Hospital DBA Carle Cancer Center
Mattoon, Illinois 61938
523
mi
from
Mattoon, IL
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The West Clinic, PC dba West Cancer Centre
Memphis, Tennessee 38104
470
mi
from
Memphis, TN
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West Virginia University
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
970
mi
from
Morgantown, WV
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Mount Kisco Medical Group, PC
Mount Kisco, New York 10549
1302
mi
from
Mount Kisco, NY
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Northern Westchester Hospital
Mount Kisco, New York 10549
1302
mi
from
Mount Kisco, NY
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