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