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

Summary

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.

Conditions

• Breast Cancer

Interventions

DRUG

lapatinib ditosylate

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.

GENETIC

TdT-mediated dUTP nick end labeling assay

Genetic analysis of tumor tissue

GENETIC

gene expression analysis

Genetic analysis of tumor tissue.

GENETIC

microarray analysis

Genetic analysis of tumor tissue.

OTHER

immunohistochemistry staining method

Laboratory analysis of tumor tissue.

PROCEDURE

biopsy

Serial biopsies by skin punch or core biopsy or fine needle aspiration.

RADIATION

radiation therapy

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• UNC Lineberger Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Elizabeth C. Dees, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-04-30

Primary Completion

2010-06-30

Completion

2012-08-31

Countries

• United States

Study Locations