A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting



Status:Active, not recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 29, 2013
End Date:March 31, 2020

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Trial Summary
Trial Overview
Inclusion Criteria
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
design study of the combination of neratinib plus capecitabine versus the combination of
lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
directed regimens in the metastatic setting.

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
design study of the combination of neratinib plus capecitabine versus the combination of
lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to
one of the following treatment arms:

- Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2 twice
daily [BID])

- Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2
BID)

Patients will receive either neratinib plus capecitabine combination or lapatinib plus
capecitabine combination until the occurrence of death, disease progression, unacceptable
toxicity, or other specified withdrawal criterion.

Inclusion Criteria:

- Aged ≥18 years at signing of informed consent.

- Histologically confirmed MBC, current stage IV.

- Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+,
with confirmatory fluorescence in situ hybridization (FISH) +.

- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast
cancer.

Exclusion Criteria:

- Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2
directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.
We found this trial at
105
sites
Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Cleveland Clinic Taussig Cancer Center
2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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UT Southwestern Medical Center
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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UCLA Hematology Oncology
Alhambra, California 91801
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Alhambra, CA
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Innovative Clinical Research Institute
Anaheim, California 92801
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Anaheim, CA
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Mission Hospital
509 Biltmore Ave
Asheville, North Carolina 28801
(828) 213-1111
Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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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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Emory University/Winship Cancer Institute
Atlanta, Georgia 30322
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Atlanta, GA
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Comprehensive Blood and Cancer Center
Bakersfield, California 93309
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland 21231
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COIBA Centro de Oncología e Investigación Buenos Aires
Berazategui, Buenos Aires
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Florida Cancer Research Institute
Boca Raton, Florida 33428
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Dana-Farber Cancer Institute
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Ironwood Cancer and Research Centers
Chandler, Arizona 85224
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Resurrection Medical Group
Chicago, Illinois 60057
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University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44012
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North Shore Oncology-Hematology Associates, Ltd.
Crystal Lake, Illinois 60014
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Karmanos Cancer Institute
Detroit, Michigan 48201
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Innovative Clinical Research Institute
Downey, California 90241
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North Shore Hematology Oncology Association PC
East Setauket, New York 11733
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Poudre Valley Hospital
1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Front Range Cancer Specialists
2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Compassionate Cancer Care Medical Group, Inc
Fountain Valley, California 92708
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St. Jude Heritage Medical Group
Fullerton, California 92835
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St. Jude Heritage Medical Group
Fullerton, California 92835
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West Clinic
Germantown, Tennessee 38138
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Ironwood Cancer and Research Centers
Gilbert, Arizona 95297
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Innovative Clinical Research Institute
Glendale, California 91204
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Cancer Care and Hematology - Greeley
Greeley, Colorado 80631
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Marin Cancer Care, Inc.
Greenbrae, California 94904
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UPMC Cancer Pavillion
Greensburg, Pennsylvania 15601
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Primary Healthcare Associates, SC
Harvey, Illinois 60426
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Hershey Medical Center
Hershey, Pennsylvania 17033
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North Shore Hematology Oncology
Highland Park, Illinois 60035
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Primary Health Oncology
Hobart, Indiana 46342
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Hobart, IN
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St Mary Medical Center
1500 South Lake Park Avenue
Hobart, Indiana 46342
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Memorial Regional Hospital
Hollywood, Florida 33021
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OnCare Hawaii, Inc.
Honolulu, Hawaii 96813
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Queen's Medical Center
1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Straub Clinic And Hospital
888 S King St
Honolulu, Hawaii 96813
(808) 522-4000
Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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University of Hawaii Cancer Center
Honolulu, Hawaii 96813
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Smith Clinic
Houston, Texas 77054
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UCLA Hematology Oncology
Irvine, California 92604
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Irvine, CA
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Jackson Oncology Associates
Jackson, Mississippi 39202
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Jackson, MS
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Mississippi Baptist Medical Center
Jackson, Mississippi 39202
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Jackson, MS
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Jackson Oncology Associates
Jackson, Mississippi 39202
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University of California, San Diego Medical Center
La Jolla, California 92093
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University of California San Diego, Moores Cancer Center
La Jolla, California 92093
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Clinical Research Alliance, Inc.
Lake Success, New York 11042
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NYU Langone Medical Center
Lake Success, New York 11042
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North Shore Oncology-Hematology Associates, Ltd.
Libertyville, Illinois 60048
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Innovative Clinical Research Institute
Long Beach, California 90805
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Norton Cancer Institute - Pavilion
Louisville, Kentucky 40202
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Norton Cancer Institute, Suburban
Louisville, Kentucky 40207
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Norton Cancer Institute - Audubon
Louisville, Kentucky 40217
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Medical Clinic at Centerra PC
Loveland, Colorado 80538
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Loveland, CO
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Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station
Lutherville, Maryland 21093
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The West Clinic, PC
100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Ironwood Cancer and Research Centers
Mesa, Arizona 85206
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UPMC Cancer Pavillion
Monroeville, Pennsylvania 15146
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Innovative Clinical Research Institute
Montebello, California 90640
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Community Hospital
Munster, Indiana 46321
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The Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
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Clinical Research Alliance
New York, New York 10021
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Weill-Cornell Medical College
New York, New York 10021
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Breastlink Medical Group
Orange, California 92868
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University Hospitals Case Medical Center
Orange Village, Ohio 44122
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UCLA Hematology Oncology
Pasadena, California 91005
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Memorial Cancer Institute
Pembroke Pines, Florida 33025
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Magee-Womens Hospital
Pittsburgh, Pennsylvania 15213
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UPMC Cancer Pavillion
Pittsburgh, Pennsylvania 15323
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Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
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UPMC Cancer Pavillion
Pittsburgh, Pennsylvania 15323
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UCLA Hematology Oncology
Porter Ranch, California 91326
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Emad Ibrahim, Md, Inc
7000 Boulder Avenue
Redlands, California 92373
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Cancer Care Associates Medical Group, Inc.
Redondo Beach, California 90277
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Compassionate Cancer Care Medical Group
Riverside, California 92501
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Riverside, CA
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Washington University in St. Louis
Saint Louis, Missouri 63110
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Siteman Cancer Center-South County
Saint Louis, Missouri 63129
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Siteman Cancer Center- West County
10 Barnes West Drive
Saint Louis, Missouri 63141
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Siteman Cancer Center-St. Peters
Saint Peters, Missouri 63376
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Sharp Memorial Hospital
7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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University of California, San Diego Medical Center, Hillcrest
San Diego, California 92121
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Breastlink Medical Group Inc
Santa Ana, California 92705
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Santa Ana, CA
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Innovative Clinical Research Institute
Santa Ana, California 92705
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Cancer Center of Santa Barbara
Santa Barbara, California 93105
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Sansum Clinic
Santa Barbara, California 93105
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Central Coast Medical Oncology
Santa Maria, California 93454
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UCLA Hematology-Oncology
Santa Monica, California 90404
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Ironwood Cancer and Research Centers
Scottsdale, Arizona 85202
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Orchard Healthcare Research Inc.
Skokie, Illinois 60076
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Cancer Center of Santa Barbara
Solvang, California 93463
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City of Hope Medical Group
South Pasadena, California 91030
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Primary Healthcare Associates, SC
Tinley Park, Illinois 60477
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Innovative Clinical Research Institute
Torrance, California 90503
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The Cancer Institute at University of Maryland St. Joseph Medical Center
Towson, Maryland 21204
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UPMC Cancer Pavillion
Uniontown, Pennsylvania 15401
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UCLA Healthcare Santa Clarita Oncology
Valencia, California 91355
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Sibley Memorial Hospital
5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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