Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00098605
Phase
PHASE2
Status
Completed

Conditions

  • Central Nervous System Metastases
  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Tumors Metastatic to Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lapatinib ditosylate — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • quality-of-life assessment — PROCEDURE
    Ancillary studies
  • questionnaire administration — OTHER
    Ancillary studies

Study Details

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating brain metastases in patients with stage IV breast cancer and brain metastases.

Key Dates

Start date
Oct 31, 2004
Status verified
Jun 2013
Primary completion
Sep 30, 2006

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (lapatinib ditosylate)
    Patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate defined as the percentage of patients with a complete response (CR) or partial response (PR) in the CNS [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MA

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