Phase II Study to Investigate Concurrent Lapatinib and Radiotherapy in Locally Advanced or Locally Recurrent Breast Cancer and the Impact on Breast Cancer Stem Cells
I. To assess the clinical complete response rate (CR) after concurrent lapatinib (lapatinib
ditosylate) and radiotherapy in patients with locally advanced or locally recurrent breast
cancer that is refractory to chemotherapy.
I. To evaluate the feasibility of assessing breast cancer stem cells (BCSCs) using flow
cytometry and single cell gene expression profiling (SCGEP).
II. To determine the change in the proportion of BCSCs after combined modality therapy.
III. To evaluate the safety and efficacy of the combination of lapatinib and radiotherapy.
IV. To assess the pathologic complete response rate (pCR) in those undergoing surgical
Patients receive lapatinib ditosylate orally (PO) once daily (QD) on day 1 until completion
of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.
After completion of study treatment, patients are followed up at 2-4 weeks and then at 6-12
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients achieving complete clinical response
Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).
Up to 12 weeks
Stanford University Hospitals and Clinics
United States: Federal Government
|Stanford University Cancer Institute||Stanford, California 94305|