CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Lapatinib +2 moredrug
Likely dose
Herceptin 4mg/kgfrom 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.

Search/NCT00470847
NCT00470847Phase 1Completed

A Phase I Study of Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Nancy Lin, MD·interventional·Posted May 8, 2007·Updated May 22, 2014

In Brief

A Phase 1 clinical trial evaluating Lapatinib, Whole Brain Radiation, and 1 other intervention for Breast Cancer and Brain Metastases. Completed, enrolled 35 participants across 3 sites.

Detailed Summary

The purpose of this research study is to determine the safety of combining lapatinib plus radiation in patients with breast cancer that has spread to the brain. Depending upon the participants cancer, they may also have stereotactic radiosurgery (SRS). Lapatinib s a compound that may stop cancer cells from growing abnormally. It is thought that lapatinib might also make cancer cells more sensitive to radiation. This drug has been used in other research studies in women with breast cancer, and information from those other research studies suggests that lapatinib may help to shrink or stabilize breast tumors both inside the brain and outside the brain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2007
Enrollment StartApr 1, 2007
Primary CompletionDec 1, 2009
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 19.2 years ago

Interventions

Lapatinibdrug

Orally twice daily

Whole Brain Radiationprocedure

15 treatments over a period of 3 weeks

Herceptindrug

Herceptin 4mg/kg loading dose then 2 mg/kg IV once weekly, then once every three weeks after cycle 3.