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Completed Phase 3 Interventional Results available

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

ClinicalTrials.gov ID: NCT01808573

Public ClinicalTrials.gov record NCT01808573. 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 Apr 22, 2026, 2:53 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 STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

Study identification

NCT ID
NCT01808573
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
621 participants

Conditions and interventions

Interventions

  • capecitabine Drug
  • lapatinib Drug
  • neratinib Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

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

Study timeline

Start date
Mar 28, 2013
Primary completion
Sep 27, 2018
Completion
Dec 8, 2019
Last update posted
Jun 10, 2021

2013 – 2019

United States locations

U.S. sites
79
U.S. states
18
U.S. cities
59
Facility City State ZIP Site status
Ironwood Cancer and Research Centers Chandler Arizona 85224
Ironwood Cancer and Research Centers Gilbert Arizona 95297
Ironwood Cancer and Research Centers Mesa Arizona 85206
Ironwood Cancer and Research Centers Scottsdale Arizona 85202
UCLA Hematology Oncology Alhambra California 91801
CBCC Global Research, Inc. at Comprehensive Blood and Caner Center Bakersfield California 93309
Compassionate Cancer Care Medical Group Inc. Fountain Valley California 92708
St. Jude Heritage Medical Group Fullerton California 92834
St. Jude Heritage Medical Group Fullerton California 92835
Marin Cancer Care, Inc. Greenbrae California 94904
UCLA Hematology Oncology Irvine California 92604
University of California San Diego Medical Center La Jolla California 92037
University of California San Diego Moores Cancer Center La Jolla California 92093-0698
Breastlink Medical Group, Inc. Orange California 92868
UCLA Hematology Oncology Pasadena California 91005
UCLA Hematology Oncology Porter Ranch California 91326
Emad Ibrahim, MD Redlands California 92373
Cancer Care Associates Medical Group, Inc Redondo Beach California 90277
Compassionate Cancer Care Medical Group Riverside California 92501
University of California San Diego Medical Center - Hillcrest San Diego California 92103
Sharp Memorial Hospital San Diego California 92123
Breastlink Medical Group, Inc. Santa Ana California 92705
Cancer Center of Santa Barbara Sansum Clinic Santa Barbara California 93105
Central Coast Medical Oncology Santa Maria California 93454
UCLA Hematology Oncology Santa Monica California 90404
Cancer Center of Santa Barbara Solvang California 93463
UCLA Healthcare Santa Clarita Oncology Valencia California 91355
UCLA Hematology/Oncology Westlake Village California 91361
Sibley Memorial Hospital Washington D.C. District of Columbia 20016
Broward Medical Oncology Office Plantation Florida 33313
Florida Cancer Research Institute Plantation Florida 33324
Emory University Hospital Midtown Atlanta Georgia 30308
Emory Clinic Atlanta Georgia 30322
Emory University Winship Cancer Institute Atlanta Georgia 30322
OnCare Hawaii Honolulu Hawaii 96813
Queen's Medical Center Honolulu Hawaii 96813
Straub Clinic and Hospital Honolulu Hawaii 96813
University of Hawaii Cancer Center Honolulu Hawaii 96813
Resurrection Medical Group Chicago Illinois 60057
North Shore Oncology-Hematology Associates, Ltd. Crystal Lake Illinois 60014
Primary Healthcare Associates, SC Harvey Illinois 60426
North Shore Hematology Oncology Highland Park Illinois 60035
North Shore Oncology-Hematology Associates, Ltd. Libertyville Illinois 60048
Orchard Healthcare Research Inc Skokie Illinois 60077
Primary Health Oncology Hobart Indiana 46342
St. Mary Medical Center Hobart Indiana 46342
Community Hospital Munster Indiana 46321
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital Baltimore Maryland 21231
Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station Lutherville Maryland 21093
The Cancer Institute at University of Maryland St. Joseph Medical Center Towson Maryland 21204
Massachusetts General Hospital Boston Massachusetts 02114
Dana Farber Cancer Institute Boston Massachusetts 02215
Karmanos Cancer Institute Detroit Michigan 48201
Siteman Cancer Center - St. Peters City of Saint Peters Missouri 63376
Washington University in St. Louis St Louis Missouri 63110
Siteman Cancer Center - South County St Louis Missouri 63129
Siteman Cancer Center - West County St Louis Missouri 63141
Cancer Institute of New Jersey New Brunswick New Jersey 08901
North Shore Hematology Oncology Association PC East Setauket New York 11733
Clinical Research Alliance Lake Success New York 11042
NYU Langone Medical Center Lake Success New York 11042
Clinical Research Alliance, Inc. New York New York 10021
Weill Cornell Medical College New York New York 10065
University Hospitals Cleveland Medical Center Cleveland Ohio 44106
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195
University Hospitals Case Medical Center Orange Ohio 44122
UPMC Cancer Pavillion Greensburg Pennsylvania 15601
Hershey Medical Center Hershey Pennsylvania 17033
UPMC Cancer Pavillion Monroeville Pennsylvania 15146
Magee Women's Hospital Pittsburgh Pennsylvania 15213
UPMC Cancer Pavillion Pittsburgh Pennsylvania 15215
Hillman Cancer Center Pittsburgh Pennsylvania 15232
UPMC Cancer Pavillion Pittsburgh Pennsylvania 15237
UPMC Cancer Pavillion Uniontown Pennsylvania 15401
UPMC Cancer Pavillion West Mifflin Pennsylvania 15122
West Clinic PC Germantown Tennessee 38138
West Clinic PC Memphis Tennessee 38120
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75235
University of Texas Southwestern Medical Center Dallas Texas 75390

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 173 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01808573, 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 Jun 10, 2021 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01808573 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →