Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ
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.
Ductal Breast Carcinoma in Situ
HER2-positive Breast Cancer
Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Trial of Lapatinib for the Treatment of Women With DCIS Breast Cancer|
- Reduction in the percent of Ki67 positive cells [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]Analysis of the primary treatment comparison will be based on a two sample t-test comparing change in log-transformed Ki67% for placebo and treated subjects. P-values of 0.05 will be considered significant.
- Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria version 3.0 [ Time Frame: Within 5 days prior to surgery ] [ Designated as safety issue: Yes ]
- Incidence of ductal carcinoma in situ remaining at resection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]Differences in histologic response (disappearance of DCIS) will be evaluated using Fisher's exact test. Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.
- Biomarker analysis of proliferation markers [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]Correlation analysis and linear models will be used to evaluate associations among marker values at baseline and among changes in marker values and treatment. All statistical tests will be two-sided.
|Study Start Date:||January 2008|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (lapatinib ditosylate)
Patients receive lapatinib ditosylate PO once QD for 2-6 weeks until the time of surgery.
Drug: lapatinib ditosylate
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD for 2-6 weeks until the time of surgery.
Other Name: PLCBOther: laboratory biomarker analysis
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.
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.
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Helen Krontiras 205-934-3028 email@example.com|
|Principal Investigator: Helen Krontiras|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Powell H. Brown 866-319-4357 NCICTRO@mail.nih.gov|
|Principal Investigator: Powell H. Brown|
|Principal Investigator:||Powell Brown||M.D. Anderson Cancer Center|