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Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

NCT00555152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-04-20

Study results available
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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.

Conditions

  • Ductal Breast Carcinoma In Situ
  • HER2/Neu Positive

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Lapatinib Ditosylate

Given PO

OTHER

Placebo

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Powel Brown · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-19
Primary Completion
2014-08-28
Completion
2014-08-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555152 on ClinicalTrials.gov