NCT01868503

Lapatinib Ditosylate and Radiation Therapy in Treating Patients With Locally Advanced or Locally Recurrent Breast Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	Given PO
RADIATION	radiation therapy	Undergo radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2013-06-04
• Last updated: 2017-06-26
• Results posted: 2017-01-19

Locations

1 site across 1 country: United States