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
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.
Study identification
- NCT ID
- NCT01808573
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 621 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- 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
- Mar 29, 2013 (Actual)
- Primary completion
- Sep 28, 2018 (Actual)
- Completion
- Dec 9, 2019 (Actual)
- Last update posted
- Jun 11, 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 11, 2021 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01808573 live on ClinicalTrials.gov.