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
Midwestern Regional Medical Center
Zion, Illinois 60099
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Zion, IL
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Palm Beach Institute of Hematology and Oncology
2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
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from
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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from
Ashland, KY
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Texas Oncology
Austin, Texas 78731
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from
Austin, TX
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Oncology Partners Network, Ltd.
Cincinnati, Ohio 45238
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from
Cincinnati, OH
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MetroHealth Medical Center, Cancer Care Center
2500 Metrohealth Drive
Cleveland, Ohio 44109
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from
Cleveland, OH
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Missouri Cancer Associates
Columbia, Missouri 65201
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from
Columbia, MO
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Cookeville Regional Medical Center
Cookeville, Tennessee 38501
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from
Cookeville, TN
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Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526
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from
Decatur, IL
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Rocky Mountain Cancer Center
Denver, Colorado 80218
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from
Denver, CO
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El Paso Cancer Treatment Ctr - West
El Paso, Texas 79902
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from
El Paso, TX
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Central Indiana Cancer Centers
Fishers, Indiana 46037
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from
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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from
Indianapolis, IN
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University of Florida
Jacksonville, Florida 32209
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from
Jacksonville, FL
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Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri 65109
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from
Jefferson City, MO
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Center for Biomedical Research
Knoxville, Tennessee 37909
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from
Knoxville, TN
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Thompson Cancer Survival Center Thompson Oncology Group
1915 White Avenue
Knoxville, Tennessee 37916
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from
Knoxville, TN
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Arena Oncology Associates PC
Lake Success, New York 11042
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from
Lake Success, NY
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Lancaster Cancer Center
Lancaster, Pennsylvania 17601
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from
Lancaster, PA
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Owsley Brown Frazier Cancer Center (OBFCC)
215 Central Avenue
Louisville, Kentucky 40245
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from
Louisville, KY
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Hematology Oncology Associates
12993 Southern Boulevard
Loxahatchee Groves, Florida 33470
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from
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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from
Murrieta, CA
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Floyd Memorial Cancer Center of Indiana
New Albany, Indiana 47150
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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
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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
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from
Oklahoma City, OK
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Uc Irvine Medical Center
Orange, California 92868
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from
Orange, CA
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Cancer Centers of Florida
Orlando, Florida 32806
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from
Orlando, FL
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Purchase Cancer Group
Paducah, Kentucky 42001
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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
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from
Palm Springs, CA
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Oncology Specialists, SC
Park Ridge, Illinois 60068
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from
Park Ridge, IL
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Allegheny General Hospital, Allegheny Cancer Center
Pittsburgh, Pennsylvania 15212
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from
Pittsburgh, PA
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Northwest Cancer Specialists, Pc
Portland, Oregon 97213
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from
Portland, OR
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Hope Oncology
Richardson, Texas 75080
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from
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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from
San Antonio, TX
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Redwood Regional Medical Group, Inc.
Santa Rosa, California 95403
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from
Santa Rosa, CA
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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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from
Stamford, CT
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New York Oncology Hematolgy, PC
Troy, New York 12180
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from
Troy, NY
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85704
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from
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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from
Tyler, TX
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