Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Nancy Lin, MD
Study ID
NCT00470847
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    Orally twice daily
  • Whole Brain Radiation — PROCEDURE
    15 treatments over a period of 3 weeks
  • Herceptin — DRUG
    Herceptin 4mg/kg loading dose then 2 mg/kg IV once weekly, then once every three weeks after cycle 3.

Study Details

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.

Key Dates

Start date
Apr 30, 2007
Status verified
Apr 2014
Primary completion
Dec 31, 2009
Completion
Jun 30, 2012

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Lapatinib,Whole Brain Radiation,Herceptin
    Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly

Primary Outcome Measure

The Maximum Tolerated Dose of Lapatinib When Combined With Cranial Radiation in Patients With CNS Metastases From HER2-positive Breast Cancer. [ Time Frame: 5 Years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Indianapolis, IN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Indiana University Melvin and Bren Simon Cancer Center· Indianapolis, INBrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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