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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00915018

Public ClinicalTrials.gov record NCT00915018. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00915018
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
479 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 21, 2009 (Actual)
Primary completion
Aug 2013 (Actual)
Completion
Jun 28, 2018 (Actual)
Last update posted
Aug 22, 2018

2009 – 2018

United States locations

U.S. sites
36
U.S. states
19
U.S. cities
35
Facility City State ZIP Site status
Ventura County Hematology-Oncology Specialists Oxnard California 93030 —
Redwood Regional Medical Group Santa Rosa California 95403 —
Cancer Center of Central Connecticut Plainville Connecticut 06062 —
Palm Beach Institute of Hematology and Oncology Boynton Beach Florida 33435 —
North Broward Medical Center Cancer Center Deerfield Beach Florida 33064 —
Broward General Medical Center Fort Lauderdale Florida 33316 —
Mid Florida Cancer Centers Orange City Florida 32763 —
Florida Cancer Research Institute Plantation Florida 33324 —
Hematology Oncology Associates of Treasure Coast Port Saint Lucie Florida 34952 —
Phoebe Cancer Center Albany Georgia 31701 —
Dublin Hematology and Oncology Care Dublin Georgia 31021 —
Clintell Skokie Illinois 60077 —
Presence Hematology and Oncology Skokie Illinois 60077 —
Springfield Clinic Springfield Illinois 62703 —
CHRISTUS St. Frances Cabrini Hospital Alexandria Louisiana 71301 —
Hematology Oncology Services Metairie Louisiana 70006 —
Park Nicollet Institute Saint Louis Park Minnesota 55426 —
Missouri Cancer Associates Columbia Missouri 65201 —
St. John's Medical Research Institute Springfield Missouri 65807 —
Washington University School of Medicine Siteman Cancer Center St Louis Missouri 63110 —
The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials Paramus New Jersey 07652 —
Gaston Hematology and Oncology Associates Gastonia North Carolina 28054 —
Summa Health System Hospitals Akron Ohio 44304-1619 —
Warren Cancer Research Foundation Tulsa Oklahoma 74104 —
Samaritan Hematology and Oncology Consultants Corvallis Oregon 97330 —
Pawtucket Memorial Hospital Pawtucket Rhode Island 02860 —
Medical University of South Carolina Hollings Cancer Center Charleston South Carolina 29425 —
Santee Hematology Oncology Sumter South Carolina 29150 —
Tenessee Cancer Specialists Knoxville Tennessee 37909 —
Family Cancer Care Memphis Tennessee 38120 —
Texas Oncology Bedford Texas 76022 —
El Paso Cancer Treatment Center El Paso Texas 79902 —
Texas Oncology-Allison Cancer Center Midland Texas 79701 —
Southlake Oncology Southlake Texas 76092 —
Utah Cancer Specialists Salt Lake City Utah 84106 —
Charleston Area Medical Center, Health, Education, and Research Institute Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 159 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00915018, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 22, 2018 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00915018 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →