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Old 12-03-2013, 04:10 PM   #1
'lizbeth
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Post Lapatinib in Treating DCIS

Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast

This study is currently recruiting participants.
Verified October 2013 by National Cancer Institute (NCI)
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:
NCT00555152
First received: November 6, 2007
Last updated: October 16, 2013
Last verified: October 2013
History of Changes


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


Condition Intervention Breast Cancer
Ductal Breast Carcinoma in Situ
Drug: lapatinib ditosylate
Other: placebo
Other: laboratory biomarker analysis

Study Type: Interventional 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
Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Lapatinib Lapatinib Ditosylate
U.S. FDA Resources


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Proliferation, as measured by Ki67 in malignant breast cells [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Toxicity profile at each dose level [ Time Frame: Up to 5 weeks ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:
  • Incidence of ductal carcinoma in situ seen at resection [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Biomarker analysis of proliferation markers in normal breast cells and cancerous breast cells [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment: 120 Study Start Date: January 2008 Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions Experimental: Arm I (1,500 mg) Patients receive 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks
Drug: lapatinib ditosylate Given orally
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb

Other: laboratory biomarker analysis Correlative studies
Experimental: Arm II (1,000 mg) Patients receive 1,000 mg of oral lapatinib ditosylate once daily for 2-6 weeks
Drug: lapatinib ditosylate Given orally
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb

Other: laboratory biomarker analysis Correlative studies
Experimental: Arm III (750 mg) Patients receive 750 mg of oral lapatinib ditosylate once daily for 2-6 weeks
Drug: lapatinib ditosylate Given orally
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb

Other: laboratory biomarker analysis Correlative studies
Placebo Comparator: Arm IV (placebo) Patients receive oral placebo once daily for 2-6 weeks
Other: placebo Given orally
Other Name: PLCB
Other: laboratory biomarker analysis Correlative studies

Detailed Description: PRIMARY OBJECTIVES:
I. To Determine the minimal biologic dose of lapatinib ditosylate, defined as the smallest dose, when compared with placebo, that results in a statistically significant lower rate of proliferation in ductal carcinoma in situ (DCIS) breast cancer cells as measured by Ki67.
II. To determine the toxicity profile and frequency of adverse events in women with DCIS breast cancer taking lapatinib ditosylate at three doses (750 mg, 1,000 mg, and 1,500 mg) as compared with women taking placebo.
SECONDARY OBJECTIVES:
I. To determine whether lapatinib ditosylate treatment affects the incidence of DCIS seen at the time of surgical excision.
II. To determine whether treatment with lapatinib ditosylate will modulate breast tissue histology or the expression of specific biomarkers in normal and DCIS breast cancer cells, including proliferation markers (Ki67 in normal cells), apoptosis marker (cleaved caspase 3), growth factor receptors (EGFR, ErbB2, ErbB3, ErbB4), signal transduction markers (MAPK, phospho-MAPK), hormone receptors (estrogen receptor, progesterone receptor), and p27.
OUTLINE: This is a multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms.
Arm I: Patients receive 1,500 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive 1,000 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
Arm III: Patients receive 750 mg of oral lapatinib ditosylate once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
Arm IV: Patients receive oral placebo once daily for 2-6 weeks in the absence of disease progression or unacceptable toxicity.
All patients then undergo surgery. Tissue samples from initial breast biopsy and subsequent excisional biopsy are collected for the following biomarker studies: proliferation by measuring Ki67 staining in ductal carcinoma in situ (DCIS) breast cancer cells; proliferation in normal cells; apoptosis marker (cleaved caspase 3) expression and activation; phospho-MAPK activation by immunohistochemistry (IHC); total MAPK expression; peptide growth factor receptors (ErbB1 [EGFR], ErbB2 [HER-2/neu], ErbB3, ErbB4) expression; estrogen receptor and progesterone receptor proliferation and differentiation; and p27 activation.
After completion of study treatment, patients are followed for 4-5 weeks.
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