At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Neratinib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Neratinib in Patients 60 and Older With HER2 Positive Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Comprehensive Geriatric Assessment, Laboratory Biomarker Analysis, and 2 other interventions for HER2 Positive Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7. Completed, enrolled 25 participants across 7 sites.
Detailed Summary
This phase II trial studies the side effects of and how well neratinib works in treating older patients with stage IV HER2-positive breast cancer. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartDec 2016
Primary CompletionMar 2020
Study CompletionSep 2022
TodayJul 2026
First PostedFeb 3, 2016
Enrollment StartDec 2, 2016
Primary CompletionMar 12, 2020
Study CompletionSep 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.4 years ago
Interventions
Comprehensive Geriatric Assessmentother
Ancillary studies
Laboratory Biomarker Analysisother
Correlative studies
Neratinibdrug
Given PO
Pharmacological Studyother
Correlative studies