Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain Metastases
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.
|Breast Cancer Metastatic Cancer||Drug: capecitabine Drug: lapatinib ditosylate Other: circulating tumor cell analysis Other: laboratory biomarker analysis||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- 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 ]
|Study Start Date:||April 2009|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Lapatinib + capecitabine
lapatinib 1250mg/day + capecitabine 2000mg/m2/day
|Drug: capecitabine Drug: lapatinib ditosylate Other: circulating tumor cell analysis Other: laboratory biomarker analysis|
- 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 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967031
|Centre Leon Berard|
|Lyon, France, 69373|
|Principal Investigator:||Thomas Bachelot, MD||Centre Leon Berard|