Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:August 21, 2009
End Date:June 28, 2018

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A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

This study is investigating the effects of an experimental drug (neratinib) in combination
with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women
who have not received previous treatment for erbB-2-positive locally recurrent or metastatic
breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors
and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will
also compare the safety of the two regimens and as well as the quality of life of subjects
receiving either regimen.


Inclusion Criteria:

- ErbB-2 positive locally recurrent or metastatic breast cancer

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Measurable disease

- Availability of tumor tissue for HER2 status confirmation

Exclusion Criteria:

- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease

- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting

- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy

- History of heart disease

- History of gastrointestinal disease
We found this trial at
37
sites
4228 Houma Boulevard
Metairie, Louisiana 70006
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Metairie, LA
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2320 S Seacrest Blvd # 300
Boynton Beach, Florida 33435
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Port Saint Lucie, FL
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Akron, Ohio 44304
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Akron, OH
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427 West 3rd Avenue
Albany, Georgia 31701
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Albany, GA
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Alexandria, Louisiana 71301
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Alexandria, LA
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Bedford, Texas 76022
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Bedford, TX
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Charleston, SC
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Charleston, WV
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Columbia, Missouri 65201
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Columbia, MO
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Corvallis, OR
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201 East Sample Road
Deerfield Beach, Florida 33064
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Deerfield Beach, FL
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Dublin, Georgia 31021
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Dublin, GA
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El Paso, Texas 79915
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El Paso, TX
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Fort Lauderdale, Florida 33316
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Fort Lauderdale, FL
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Gastonia, North Carolina 28054
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Gastonia, NC
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1415 Old Weisgarber Road
Knoxville, Tennessee 37909
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Knoxville, TN
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6029 Walnut Grove Road
Memphis, Tennessee 38120
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Memphis, TN
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Midland, TX
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28 Woodville Road
North Adelaide, South Australia 5011
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North Adelaide,
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2776 Enterprise Road
Orange City, Florida 32763
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Orange City, FL
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Oxnard, CA
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1 Valley Health Plz
Paramus, New Jersey 07652
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Paramus, NJ
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Pawtucket, Rhode Island 02860
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Pawtucket, RI
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Plainville, Connecticut
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Plantation, Florida
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Plantation, FL
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Saint Louis, MO
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Saint Louis Park, Minnesota 55416
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Salt Lake City, Utah 84106
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Santa Rosa, California 95403
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Santa Rosa, CA
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Skokie, Illinois 60077
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Skokie, IL
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Skokie, Illinois 60077
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Skokie, IL
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Southlake, Texas 76092
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Southlake, TX
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Springfield, Illinois 62703
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Springfield, IL
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Springfield, Missouri 65807
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Sumter, South Carolina 29150
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Sumter, SC
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Tulsa, OK
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