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Neoadjuvant Trial of Lapatinib for the Treatment of Women With DCIS Breast Cancer
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.
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 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
August 19, 2009
Primary Completion Date
August 28, 2014
Completion Date
August 28, 2014
Last Updated
April 20, 2018
22
ACTUAL participants
Laboratory Biomarker Analysis
OTHER
Lapatinib Ditosylate
DRUG
Placebo
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT01905046
NCT02694809
Data Source & Attribution
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