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
Cancer Specialists of North Florida - St. Augustine
9 San Bartola Drive
Saint Augustine, Florida 32086
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Saint Augustine, FL
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Memorial Cancer Institute at Memorial Regional Hospital
1150 N 35th Ave # 330
Hollywood, Florida 33021
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Hollywood, FL
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Orlando Health
24 Sturtevant St
Orlando, Florida 32806
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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...
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Portland, OR
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Central Coast Medical Oncology Corporation
220 S Palisade Dr # 204
Santa Maria, California 93454
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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...
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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...
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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...
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The Emory Clinic
Atlanta, Georgia 30322
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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...
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Grady Health System
Atlanta, Georgia 30303
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Atlanta, GA
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Winship Cancer Institute
Atlanta, Georgia 30322
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Atlanta, GA
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Mercy Clinic St. Louis Cancer and Breast Institute
Ballwin, Missouri 63011
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Ballwin, MO
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University of Maryland
Baltimore, Maryland 20742
(301) 405-1000
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Southern California Permanente Medical Group
BellFlower, California 90706
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BellFlower, CA
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Walter Reed National Military Medical Center
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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Beverly Hills Cancer Center
Beverly Hills, California 90211
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Beverly Hills, CA
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Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care
Blacksburg, Virginia 24060
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Blacksburg, VA
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Mount Kisco Medical Group
Brewster, New York 10509
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Brewster, NY
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The Mark M. Connolly Center for Cancer and Specialty Care
Chicago, Illinois 60657
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Chicago, IL
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Kootenai Clinic Cancer Services
Coeur d'Alene, Idaho 83814
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Coeur d'Alene, ID
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The West Clinic
Corinth, Mississippi 38834
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Corinth, MS
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246
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Dallas, TX
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Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas 75231
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Dallas, TX
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Carle Foundation Hospital DBA Carle Cancer Center
Danville, Illinois 61832
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Danville, IL
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St. Vincents Hospital Sydney
Darlinghurst, New South Wales 2010
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Darlinghurst,
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Sylvester at Deerfield Beach
Deerfield Beach, Florida 33442
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Deerfield Beach, FL
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Tennessee Oncology, PLLC
Dickson, Tennessee 37055
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Dickson, TN
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Carle Foundation Hospital DBA Carle Cancer Center
Effingham, Illinois 62401
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Effingham, IL
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Texas Oncology - El Paso Cancer Treatment Center Joe Battle
El Paso, Texas 79939
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El Paso, TX
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Texas Oncology - El Paso Cancer Treatment Center Grandview
El Paso, Texas 79902
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El Paso, TX
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Texas Oncology - El Paso Cancer Treatment Center Gateway
El Paso, Texas 79915
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El Paso, TX
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Presence Infusion Care- Evanston
Evanston, Illinois 60202
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Evanston, IL
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CUMC Herbert Irving Pavilion
Fort Lee, New Jersey 07024
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Fort Lee, NJ
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Investigational Products Center (IPC)
Fort Worth, Texas 76177
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Fort Worth, TX
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Tennessee Oncology, PLLC
Franklin, Tennessee 37067
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Franklin, TN
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St. Joseph Heritage Healthcare
Fullerton, California 92835
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Fullerton, CA
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Tennessee Oncology, PLLC
Gallatin, Tennessee 37066
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Gallatin, TN
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The West Clinic, PC dba West Cancer Centre
Germantown, Tennessee 38138
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Germantown, TN
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Los Angeles Hematology Oncology Medical Group
Glendale, California 91206
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Glendale, CA
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Saint Francis Medical Center
Grand Island, Nebraska 68803
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Grand Island, NE
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Saint Francis Medical Center, Saint Francis Cancer Treatment Center
Grand Island, Nebraska 68803
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Grand Island, NE
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St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado 81501
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Grand Junction, CO
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Saint Francis Medical Center
Hastings, Nebraska 68901
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Hastings, NE
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
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Henderson, NV
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Comprehensive Cancer Centers of Nevada
Henderson, Nevada
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Henderson, NV
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Tennessee Oncology, PLLC
Hermitage, Tennessee 37076
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Hermitage, TN
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Memorial Regional Hospital
Hollywood, Florida 33021
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Hollywood, FL
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Memorial Breast Cancer Center at Memorial Regional Hospital
Hollywood, Florida 33021
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Hollywood, FL
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The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology
Houston, Texas 77030
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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...
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UCLA Hematology Oncology Irvine
Irvine, California 92604
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Irvine, CA
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US Oncology Investigational Products Center
Irving, Texas 75063
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Irving, TX
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Cancer Specialist of North Florida, Pharmacy
Jacksonville, Florida 32256
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Jacksonville, FL
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Cancer Specialists of North Florida-Southpoint
Jacksonville, Florida 32256
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Jacksonville, FL
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UCLA Hematology Oncology- Laguna Hills
Laguna Hills, California 92653
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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...
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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...
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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...
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Comprehensive Cancer Centers of Nevada Research Department
3730 South Eastern Avenue
Las Vegas, Nevada 89119
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Las Vegas, NV
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Tennessee Oncology, PLLC
Lebanon, Tennessee 37087
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Lebanon, TN
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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TRIO-US Central Administration
Los Angeles, California 90095
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TRIO-US Central Administration
Los Angeles, California 90095
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TRIO-US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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Ucla Hematology/Oncology
Los Angeles, California 90095
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Los Angeles, CA
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Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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Los Angeles Hematology/Oncology Medical Group
Los Angeles, California 90017
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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UCLA West Medical Pharmacy, Attn: Steven L. Wong
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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UCLA West Medical Pharmacy (Drug Management Only)
Los Angeles, California 90091
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Los Angeles, CA
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Regulatory Management Only: TRIO-US Central Administration
Los Angeles, California 90095
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Los Angeles, CA
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TRIO-US Central Administration (Regulatory Management only)
Los Angeles, California 93309
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Los Angeles, CA
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Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharm.D.
Los Angeles, California 90095
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Translational Research Management
Los Angeles, California 90045
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Southern California Permanente Medical Group
Los Angeles, California 90027
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James Graham Brown Cancer Center and University Hospital
Louisville, Kentucky 40202
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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...
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Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Low Moor, Virginia 24457
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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...
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Northwest Georgia Oncology Centers, PC
Marietta, Georgia 30060
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Marietta, GA
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Carle Foundation Hospital DBA Carle Cancer Center
Mattoon, Illinois 61938
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Mattoon, IL
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The West Clinic, PC dba West Cancer Centre
Memphis, Tennessee 38104
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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...
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Mount Kisco Medical Group, PC
Mount Kisco, New York 10549
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