Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:February 4, 2009
End Date:June 3, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib
and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced
breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and
extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also
compare the safety of the two regimens and to compare quality of life of patients taking the
two regimens.


Inclusion Criteria:

- Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer

- Prior use of Herceptin (trastuzumab), and a taxane

- Adequate cardiac and renal function

Exclusion Criteria:

- More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda
(capecitabine) and / or Tykerb (lapatinib) [Tyverb]

- Bone as the only site of disease

- Active central nervous system metastases (subjects should be stable and off
anticonvulsants and steroids)

- Significant gastrointestinal disorder with diarrhea as major symptom
We found this trial at
45
sites
Rocky Mountain Cancer Center
Denver, Colorado 80218
818
mi
from 91732
Denver, CO
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Palm Beach Institute of Hematology and Oncology
2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
2309
mi
from 91732
Boynton Beach, FL
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Hematology Oncology Associates of Treasure Coast
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
2276
mi
from 91732
Port Saint Lucie, FL
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Ashland Bellefonte Cancer Center
Ashland, Kentucky 41101
1981
mi
from 91732
Ashland, KY
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Texas Oncology
Austin, Texas 78731
1208
mi
from 91732
Austin, TX
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Oncology Partners Network, Ltd.
Cincinnati, Ohio 45238
1874
mi
from 91732
Cincinnati, OH
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MetroHealth Medical Center, Cancer Care Center
2500 Metrohealth Drive
Cleveland, Ohio 44109
2031
mi
from 91732
Cleveland, OH
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Missouri Cancer Associates
Columbia, Missouri 65201
1462
mi
from 91732
Columbia, MO
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Cookeville Regional Medical Center
Cookeville, Tennessee 38501
1833
mi
from 91732
Cookeville, TN
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Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526
1645
mi
from 91732
Decatur, IL
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El Paso Cancer Treatment Ctr - West
El Paso, Texas 79902
686
mi
from 91732
El Paso, TX
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Central Indiana Cancer Centers
Fishers, Indiana 46037
1801
mi
from 91732
Fishers, IN
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The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
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Robert R. Carroll, MD, PA
6400 West Newberry Road
Gainesville, Florida 32605
2100
mi
from 91732
Gainesville, FL
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Hematology Oncology of Indiana
Indianapolis, Indiana 46260
1792
mi
from 91732
Indianapolis, IN
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University of Florida
Jacksonville, Florida 32209
2139
mi
from 91732
Jacksonville, FL
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Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri 65109
1462
mi
from 91732
Jefferson City, MO
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Center for Biomedical Research
Knoxville, Tennessee 37909
1918
mi
from 91732
Knoxville, TN
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Thompson Cancer Survival Center Thompson Oncology Group
1915 White Avenue
Knoxville, Tennessee 37916
1922
mi
from 91732
Knoxville, TN
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Arena Oncology Associates PC
Lake Success, New York 11042
2448
mi
from 91732
Lake Success, NY
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Lancaster Cancer Center
Lancaster, Pennsylvania 17601
2314
mi
from 91732
Lancaster, PA
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Owsley Brown Frazier Cancer Center (OBFCC)
215 Central Avenue
Louisville, Kentucky 40245
1812
mi
from 91732
Louisville, KY
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Hematology Oncology Associates
12993 Southern Boulevard
Loxahatchee Groves, Florida 33470
2294
mi
from 91732
Loxahatchee Groves, FL
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University of Tennessee Cancer Institute
Memphis, Tennessee
1586
mi
from 91732
Memphis, TN
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Mercy Research Institute
Miami, Florida
2320
mi
from 91732
Miami, FL
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Southwest Cancer Care
Murrieta, California 92562
58
mi
from 91732
Murrieta, CA
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Floyd Memorial Cancer Center of Indiana
New Albany, Indiana 47150
1809
mi
from 91732
New Albany, IN
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Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center
New York, New York 10065
2435
mi
from 91732
New York, NY
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University of Oklahoma Health Sciences Center Dept. of Hematology Oncology
801 Northeast 13th Street
Oklahoma City, Oklahoma 73104
1166
mi
from 91732
Oklahoma City, OK
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Uc Irvine Medical Center
Orange, California 92868
21
mi
from 91732
Orange, CA
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Cancer Centers of Florida
Orlando, Florida 32806
2186
mi
from 91732
Orlando, FL
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Purchase Cancer Group
Paducah, Kentucky 42001
1656
mi
from 91732
Paducah, KY
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Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center
1180 North Indian Canyon Drive
Palm Springs, California 92262
85
mi
from 91732
Palm Springs, CA
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Oncology Specialists, SC
Park Ridge, Illinois 60068
1720
mi
from 91732
Park Ridge, IL
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Allegheny General Hospital, Allegheny Cancer Center
Pittsburgh, Pennsylvania 15212
2119
mi
from 91732
Pittsburgh, PA
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Northwest Cancer Specialists, Pc
Portland, Oregon 97213
828
mi
from 91732
Portland, OR
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Hope Oncology
Richardson, Texas 75080
1225
mi
from 91732
Richardson, TX
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Cancer Care Network of South Texas-HOAST
9102 Floyd Curl Drive
San Antonio, Texas 78229
1180
mi
from 91732
San Antonio, TX
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Redwood Regional Medical Group, Inc.
Santa Rosa, California 95403
402
mi
from 91732
Santa Rosa, CA
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Mater Private Centre for HOCA
293 Vulture Street
South Brisbane, Queensland 4101
7198
mi
from 91732
South Brisbane,
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Hematology Oncology Associates, PC
Stamford, Connecticut 06902
2455
mi
from 91732
Stamford, CT
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New York Oncology Hematolgy, PC
Troy, New York 12180
2443
mi
from 91732
Troy, NY
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85704
423
mi
from 91732
Tucson, AZ
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East Texas Medical Center Cancer Institute, Tyler Hematology Oncology
721 Clinic Drive
Tyler, Texas 75701
1316
mi
from 91732
Tyler, TX
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Midwestern Regional Medical Center
Zion, Illinois 60099
1725
mi
from 91732
Zion, IL
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