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
Central Indiana Cancer Centers
Fishers, Indiana 46037
652
mi
from
Fishers, IN
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Palm Beach Institute of Hematology and Oncology
2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
1293
mi
from
Boynton Beach, FL
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Hematology Oncology Associates of Treasure Coast
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
1247
mi
from
Port Saint Lucie, FL
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Ashland Bellefonte Cancer Center
Ashland, Kentucky 41101
825
mi
from
Ashland, KY
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Texas Oncology
Austin, Texas 78731
511
mi
from
Austin, TX
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Oncology Partners Network, Ltd.
Cincinnati, Ohio 45238
720
mi
from
Cincinnati, OH
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MetroHealth Medical Center, Cancer Care Center
2500 Metrohealth Drive
Cleveland, Ohio 44109
894
mi
from
Cleveland, OH
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Missouri Cancer Associates
Columbia, Missouri 65201
310
mi
from
Columbia, MO
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Cookeville Regional Medical Center
Cookeville, Tennessee 38501
687
mi
from
Cookeville, TN
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Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526
499
mi
from
Decatur, IL
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Rocky Mountain Cancer Center
Denver, Colorado 80218
408
mi
from
Denver, CO
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El Paso Cancer Treatment Ctr - West
El Paso, Texas 79902
641
mi
from
El Paso, TX
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The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Robert R. Carroll, MD, PA
6400 West Newberry Road
Gainesville, Florida 32605
1045
mi
from
Gainesville, FL
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Hematology Oncology of Indiana
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
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University of Florida
Jacksonville, Florida 32209
1065
mi
from
Jacksonville, FL
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Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri 65109
307
mi
from
Jefferson City, MO
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Center for Biomedical Research
Knoxville, Tennessee 37909
772
mi
from
Knoxville, TN
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Thompson Cancer Survival Center Thompson Oncology Group
1915 White Avenue
Knoxville, Tennessee 37916
776
mi
from
Knoxville, TN
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Arena Oncology Associates PC
Lake Success, New York 11042
1303
mi
from
Lake Success, NY
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Lancaster Cancer Center
Lancaster, Pennsylvania 17601
1164
mi
from
Lancaster, PA
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Owsley Brown Frazier Cancer Center (OBFCC)
215 Central Avenue
Louisville, Kentucky 40245
657
mi
from
Louisville, KY
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Hematology Oncology Associates
12993 Southern Boulevard
Loxahatchee Groves, Florida 33470
1276
mi
from
Loxahatchee Groves, FL
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University of Tennessee Cancer Institute
Memphis, Tennessee
467
mi
from
Memphis, TN
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Mercy Research Institute
Miami, Florida
1321
mi
from
Miami, FL
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Southwest Cancer Care
Murrieta, California 92562
1124
mi
from
Murrieta, CA
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Floyd Memorial Cancer Center of Indiana
New Albany, Indiana 47150
653
mi
from
New Albany, IN
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Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center
New York, New York 10065
1289
mi
from
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
157
mi
from
Oklahoma City, OK
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Uc Irvine Medical Center
Orange, California 92868
1154
mi
from
Orange, CA
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Cancer Centers of Florida
Orlando, Florida 32806
1144
mi
from
Orlando, FL
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Purchase Cancer Group
Paducah, Kentucky 42001
504
mi
from
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
1081
mi
from
Palm Springs, CA
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Oncology Specialists, SC
Park Ridge, Illinois 60068
604
mi
from
Park Ridge, IL
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Allegheny General Hospital, Allegheny Cancer Center
Pittsburgh, Pennsylvania 15212
971
mi
from
Pittsburgh, PA
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Northwest Cancer Specialists, Pc
Portland, Oregon 97213
1380
mi
from
Portland, OR
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Hope Oncology
Richardson, Texas 75080
335
mi
from
Richardson, TX
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Cancer Care Network of South Texas-HOAST
9102 Floyd Curl Drive
San Antonio, Texas 78229
569
mi
from
San Antonio, TX
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Redwood Regional Medical Group, Inc.
Santa Rosa, California 95403
1351
mi
from
Santa Rosa, CA
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Mater Private Centre for HOCA
293 Vulture Street
South Brisbane, Queensland 4101
8348
mi
from
South Brisbane,
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Hematology Oncology Associates, PC
Stamford, Connecticut 06902
1311
mi
from
Stamford, CT
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New York Oncology Hematolgy, PC
Troy, New York 12180
1313
mi
from
Troy, NY
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85704
832
mi
from
Tucson, AZ
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East Texas Medical Center Cancer Institute, Tyler Hematology Oncology
721 Clinic Drive
Tyler, Texas 75701
400
mi
from
Tyler, TX
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Midwestern Regional Medical Center
Zion, Illinois 60099
618
mi
from
Zion, IL
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