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

Sponsor
UNICANCER
Study ID
NCT00967031
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • capecitabine — DRUG
  • lapatinib ditosylate — DRUG
  • circulating tumor cell analysis — OTHER
  • laboratory biomarker analysis — OTHER

Study Details

RATIONALE: Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with capecitabine works in treating patients with stage IV breast cancer and brain metastases.

Key Dates

Start date
Apr 30, 2009
Status verified
Jan 2013
Primary completion
Feb 29, 2012

Study Design

Enrollment
45 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib + capecitabine
    lapatinib 1250mg/day + capecitabine 2000mg/m2/day

Primary Outcome Measure

Objective response rate [ Time Frame: february 2012 ]

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