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.
OBJECTIVES: Primary * To assess the objective response rate by volumetric analysis of brain metastasis as assessed by MRI in patients with HER2-positive stage IV breast cancer treated with lapatinib ditosylate and capecitabine. Secondary * To document any toxicity evaluated by NCI CTC v3.0. * To assess the time to radiotherapy. * To document the time to disease progression in the central nervous system (CNS) of these patients. * To evaluate the overall response rate for extra-CNS disease. * To assess the clinical benefit (complete response, partial response, and stable disease for ≥ 6 months) for both CNS and extra-CNS disease in these patients. Tertiary * To evaluate serum proteomics and metabonomics markers as predictors of response. * To evaluate the predictive value of circulating tumor cells (CTC) on response. OUTLINE: This is a multicenter study. Patients receive oral lapatinib ditosylate once daily. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Centre Leon Berard
Lyon, France
Objective response rate
Time frame: february 2012
Toxicity as assessed by NCI CTC v3.0
Time frame: february 2012
Time to radiotherapy
Time frame: february 2012
Time to disease progression
Time frame: february 2012
Overall response rate
Time frame: february 2012
Clinical benefit (complete response, partial response, and stable disease for at least 6 months)
Time frame: february 2012
Evaluation of serum proteomics and metabonomics markers as predictors of response
Time frame: may 2012
Evaluation of the predictive value of circulating tumor cells on response
Time frame: february 2012
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