At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
BKM120 +2 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 Multicenter Single-arm Study of BKM120 Plus Capecitabine for Breast Cancer Patients With Brain Metastases
In Brief
A Phase 2 clinical trial evaluating BKM120, capecitabine, and 1 other intervention for Brain Metastases and 2 related conditions. Completed, enrolled 10 participants across 1 site.
Detailed Summary
This is a study to determine the safety and effectiveness of BKM120 plus capecitabine in breast cancer patients with brain metastases. Both capecitabine and BMK120 have previously shown activity in patients with breast cancer. Like capecitabine, BMK120 is also effective in crossing the blood brain barrier making it a preferred candidate for its evaluation in patients with metastatic breast cancer (MBC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Metastases, Breast Cancer, Metastatic Breast Cancer
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartMay 2014
Primary CompletionMar 2019
TodayJul 2026
First PostedDec 4, 2013
Enrollment StartMay 29, 2014
Primary CompletionMar 29, 2019
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 12.6 years ago
Interventions
BKM120drug
capecitabinedrug
Trastuzumabdrug