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Completed Phase 2 Interventional Results available

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

ClinicalTrials.gov ID: NCT00777101

Public ClinicalTrials.gov record NCT00777101. 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 19, 2026, 10:58 AM 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 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

Brief summary

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

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.

Study identification

NCT ID
NCT00777101
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
233 participants

Conditions and interventions

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
Feb 4, 2009 (Actual)
Primary completion
Mar 2011 (Actual)
Completion
Jun 3, 2018 (Actual)
Last update posted
Aug 9, 2018

2009 – 2018

United States locations

U.S. sites
44
U.S. states
16
U.S. cities
43
Facility City State ZIP Site status
Arizona Oncology Associates HOPE Tucson Arizona 85704-7891 —
Southwest Cancer Care Murrieta California 92562 —
UC Irvine Medical Center Orange California 92868-3298 —
Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center Palm Springs California 92262 —
Redwood Regional Medical Group, Inc. Santa Rosa California 95403 —
Rocky Mountain Cancer Center Denver Colorado 80220 —
Hematology Oncology Associates, P.C. Stamford Connecticut 06902 —
Palm Beach Institute of Hematology & Oncology Boynton Beach Florida 33435 —
Robert R. Carroll, MD, PA Gainesville Florida 32605 —
University of Florida Jacksonville Florida 32209 —
Hematology Oncology Associates Loxahatchee Groves Florida 33470 —
Mercy Research Institute Miami Florida 33133 —
Cancer Centers of Florida Orlando Florida 32806 —
Hematology Oncology Associates of the Treasure Coast Port Saint Lucie Florida 34952 —
Cancer Care Specialists Of Central Illinois Decatur Illinois 62526 —
Oncology Specialists, SC Park Ridge Illinois 60068 —
Midwestern Regional Medical Center Zion Illinois 60099 —
Central Indiana Cancer Centers Fishers Indiana 46037 —
Hematology Oncology of Indiana Indianapolis Indiana 46260-2082 —
Floyd Memorial Cancer Center of Indiana New Albany Indiana 47150 —
Ashland-Bellefonte Cancer Center Ashland Kentucky 41101 —
Owsley Brown Frazier Cancer Center (OBFCC) Louisville Kentucky 40245 —
Purchase Cancer Group Paducah Kentucky 42001 —
Missouri Cancer Associates Columbia Missouri 65201 —
Capitol Comprehensive Cancer Care Clinic Jefferson City Missouri 65109 —
Arena Oncology Associates, PC Lake Success New York 11042 —
Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center New York New York 10065 —
New York Oncology Hematolgy, PC Troy New York 12180 —
Oncology Partners Network Cincinnati Ohio 45247 —
MetroHealth Medical Center, Cancer Care Center Cleveland Ohio 44109 —
University of Oklahoma Health Sciences Center Dept. of Hematology Oncology Oklahoma City Oklahoma 73104 —
Northwest Cancer Specialists, PC Portland Oregon 97213 —
Lancaster Cancer Center Lancaster Pennsylvania 17605 —
Allegheny General Hospital Allegheny Cancer Center Pittsburgh Pennsylvania 15212 —
Cookeville Regional Medical Center Cookeville Tennessee 38501 —
Center for Biomedical Research Knoxville Tennessee 37909 —
Thompson Cancer Survival Center Thompson Oncology Group Knoxville Tennessee 37916 —
University of Tennessee Cancer Institute Memphis Tennessee 38104 —
Texas Oncology, P.A. Austin Texas 78731-4214 —
El Paso Cancer Treatment Center - West El Paso Texas 79902 —
The Center for Cancer and Blood Disorders Fort Worth Texas 76104 —
HOPE Oncology Richardson Texas 75080 —
Cancer Care Network of South Texas-HOAST San Antonio Texas 78229 —
East Texas Medical Center Cancer Institute, Tyler Hematology Oncology Tyler Texas 75701-2043 —

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 108 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00777101, 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 9, 2018 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00777101 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →