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
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)
Other study identifiers
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · WHO
interventional
621
28 countries
252
Study Start
March 29, 2013
Actual (reported)Primary Completion
September 28, 2018
Actual (reported)Study Completion
December 9, 2019
Actual (reported)Brief Summary
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 621 participants
- Study completion date
December 9, 2019
Actual (reported)- Listed locations
- 28 countries · 252 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
March 4, 2013
Actual (reported)First Posted
March 11, 2013
Actual (reported)Study Start
March 29, 2013
Actual (reported)Primary Completion
September 28, 2018
Actual (reported)Study Completion
December 9, 2019
Actual (reported)Results Posted
December 11, 2019
Actual (reported)
- Last Updated
- June 11, 2021
- Status Verified
- May 2021
- Results QC Date
- December 9, 2019
- Last Update Submitted
- May 18, 2021