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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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
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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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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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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Alhambra, California 91801
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Anaheim, California 92801
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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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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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Atlanta, Georgia 30322
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Bakersfield, California 93309
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Boca Raton, Florida 33428
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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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Chandler, Arizona 85224
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Chicago, Illinois 60057
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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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Detroit, Michigan 48201
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Downey, California 90241
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East Setauket, New York 11733
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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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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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Fountain Valley, California 92708
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Fullerton, California 92835
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Fullerton, California 92835
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Germantown, Tennessee 38138
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Gilbert, Arizona 95297
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Glendale, California 91204
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Greeley, Colorado 80631
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Greenbrae, California 94904
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Greensburg, Pennsylvania 15601
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Harvey, Illinois 60426
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Hershey, Pennsylvania 17033
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Highland Park, Illinois 60035
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Hobart, Indiana 46342
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1500 South Lake Park Avenue
Hobart, Indiana 46342
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Hollywood, Florida 33021
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Honolulu, Hawaii 96813
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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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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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Honolulu, Hawaii 96813
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Houston, Texas 77054
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Irvine, California 92604
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Jackson, Mississippi 39202
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Jackson, Mississippi 39202
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Jackson, Mississippi 39202
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Lake Success, New York 11042
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Lake Success, New York 11042
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Long Beach, California 90805
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Louisville, Kentucky 40202
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Louisville, Kentucky 40217
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Loveland, Colorado 80538
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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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Monroeville, Pennsylvania 15146
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Montebello, California 90640
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Munster, Indiana 46321
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New Brunswick, New Jersey 08901
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New York, New York 10021
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Orange, California 92868
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Orange Village, Ohio 44122
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Pasadena, California 91005
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Pembroke Pines, Florida 33025
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, Pennsylvania 15323
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Pittsburgh, Pennsylvania 15232
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Porter Ranch, California 91326
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7000 Boulder Avenue
Redlands, California 92373
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63129
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10 Barnes West Drive
Saint Louis, Missouri 63141
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Saint Peters, Missouri 63376
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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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Santa Ana, California 92705
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Santa Ana, California 92705
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Santa Barbara, California 93105
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Santa Maria, California 93454
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Santa Monica, California 90404
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Scottsdale, Arizona 85202
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Skokie, Illinois 60076
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Solvang, California 93463
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South Pasadena, California 91030
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Tinley Park, Illinois 60477
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Torrance, California 90503
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Uniontown, Pennsylvania 15401
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Valencia, California 91355
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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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