Lapatinib Ditosylate in Treating Patients With Ductal Breast Carcinoma In Situ

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00555152
Status
Completed

Conditions

  • Ductal Breast Carcinoma In Situ
  • HER2/Neu Positive

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lapatinib Ditosylate — DRUG
    Given PO
  • Placebo — OTHER
    Given PO

Study Details

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.

Key Dates

Start date
Aug 19, 2009
Status verified
Mar 2018
Primary completion
Aug 28, 2014
Completion
Aug 28, 2014

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (lapatinib ditosylate)
    Patients receive lapatinib ditosylate PO once QD for 2-6 weeks until the time of surgery.
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO QD for 2-6 weeks until the time of surgery.

Primary Outcome Measure

Proliferation (Ki67 IHC) in Ductal Breast Carcinoma In Situ (DCIS) [ Time Frame: 2-6 weeks from baseline to surgery, up to 6 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham Cancer Center· Birmingham, ALM D Anderson Cancer Center· Houston, TX

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