Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
