NCT00967031

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

A Multicenter Phase II Clinical Trial Assessing the Efficacy of the Combination of Lapatinib and Capecitabine in Patients With Non Pretreated Brain Metastasis From HER2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	lapatinib ditosylate
OTHER	circulating tumor cell analysis
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-02-01
• First posted: 2009-08-27
• Last updated: 2013-01-18

Locations

1 site across 1 country: France