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
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Jackson, Mississippi 39202
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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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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 40207
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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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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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Pittsburgh, Pennsylvania 15323
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Porter Ranch, California 91326
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7000 Boulder Avenue
Redlands, California 92373
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Redondo Beach, California 90277
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Riverside, California 92501
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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 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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