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
- 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.
- 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
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Thomas Bachelot, MD
Centre Leon Berard
AFSSAPS : agence française de sécurité Sanitaire des produits de santé