Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor: UNC Lineberger Comprehensive Cancer Center
Study ID: NCT00379509
Phase: PHASE1
Status: Completed

Conditions

Breast Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - 120 Years
Healthy Volunteers: Not accepted

Interventions

lapatinib ditosylate — DRUG
Patients will be assigned in cohorts of 3. Dose levels of GW572106 will include 500mg, 1000mg,1500 mg (additional levels at 750 mg and 1250 mg will be added if needed). Lapatinib is an oral drug. It is taken every day.
TdT-mediated dUTP nick end labeling assay — GENETIC
Genetic analysis of tumor tissue
gene expression analysis — GENETIC
Genetic analysis of tumor tissue.
microarray analysis — GENETIC
Genetic analysis of tumor tissue.
immunohistochemistry staining method — OTHER
Laboratory analysis of tumor tissue.
biopsy — PROCEDURE
Serial biopsies by skin punch or core biopsy or fine needle aspiration.
radiation therapy — RADIATION
Radiotherapy will be delivered at standard dose and fractionation. For patients who have not received previous locoregional radiotherapy, 50-56 Gy will be delivered to the regional lymph nodes and/or chest wall at a dose of 2 Gy per fraction, 5 days per week followed by a boost to the sites of gross involvement to a total dose of 60-70 Gy over a course of 6-7 weeks. For patients who have received adjuvant radiotherapy, a dose of 35-45 Gy will be delivered to sites of chest wall involvement at a dose of 1.8 Gy per fraction over 4-5 weeks. In either de novo or reirradiated settings, the total dose to the brachial plexus will not exceed 60 Gy.

Study Details

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving lapatinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer.