This phase II trial studies how well lapatinib ditosylate and radiation therapy work in treating patients with locally advanced or locally recurrent breast cancer. Lapatinib ditosylate 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 ditosylate together with radiation therapy may be an effective treatment for breast cancer.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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 resection. OUTLINE: 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 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Stanford University Cancer Institute
Stanford, California, United States
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).
Time frame: Up to 12 weeks
Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP
Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.
Time frame: 12 weeks
Change in the Proportion of BCSCs
Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.
Time frame: Baseline to 12 weeks
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Adverse events will be tabulated by organ system and severity.
Time frame: Up to 12 weeks
Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes
Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.
Time frame: Up to 12 weeks
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