NCT00555152

Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

Neoadjuvant Trial of Lapatinib for the Treatment of Women With DCIS Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase I/II trial studies the side effects and best dose of lapatinib ditosylate and to see how well it works in treating patients with ductal breast carcinoma in situ. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. Determine whether lapatinib (lapatinib ditosylate) therapy at the dose of 1000 mg results in a statistically significantly lower rate of proliferation in ductal carcinoma in situ (DCIS) breast cancer cells as measured by Ki67 when compared to placebo. II. Determine the toxicity profile and frequency of adverse events in women with DCIS breast cancer taking lapatinib at 1000 mg as compared to women taking placebo. SECONDARY OBJECTIVES: I. Determine whether lapatinib treatment affects the incidence of DCIS seen at the time of surgical excision. II. Determine whether treatment with lapatinib will modulate breast tissue histology or the expression of specific biomarkers in normal and DCIS breast cancer cells. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive lapatinib ditosylate orally (PO) once daily (QD) for 2-6 weeks until the time of surgery. ARM II: Patients receive placebo PO QD for 2-6 weeks until the time of surgery. After completion of study treatment, patients are followed for 4-5 weeks.

Conditions

• Ductal Breast Carcinoma In Situ
• HER2/Neu Positive

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Lapatinib Ditosylate	Given PO
OTHER	Placebo	Given PO

Timeline

• Start date: 2009-08-19
• Primary completion: 2014-08-28
• Completion: 2014-08-28
• First posted: 2007-11-07
• Last updated: 2018-04-20
• Results posted: 2015-11-25

Locations

2 sites across 1 country: United States