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

Phase 2

Completed

• Conditions: Breast Cancer; Metastatic Cancer
• Interventions: Drug: capecitabine; Drug: lapatinib ditosylate; Other: circulating tumor cell analysis; Other: laboratory biomarker analysis

• Registration Number: NCT00967031
• Lead Sponsor: UNICANCER

Brief 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Primary Completion: 2012-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lapatinib + capecitabine	lapatinib ditosylate	lapatinib 1250mg/day + capecitabine 2000mg/m2/day
Lapatinib + capecitabine	circulating tumor cell analysis	lapatinib 1250mg/day + capecitabine 2000mg/m2/day
Lapatinib + capecitabine	laboratory biomarker analysis	lapatinib 1250mg/day + capecitabine 2000mg/m2/day
Lapatinib + capecitabine	capecitabine	lapatinib 1250mg/day + capecitabine 2000mg/m2/day

Primary Outcome Measures

Name	Time	Method
Objective response rate	february 2012

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by NCI CTC v3.0	february 2012
Time to radiotherapy	february 2012
Time to disease progression	february 2012
Overall response rate	february 2012
Clinical benefit (complete response, partial response, and stable disease for at least 6 months)	february 2012
Evaluation of serum proteomics and metabonomics markers as predictors of response	may 2012
Evaluation of the predictive value of circulating tumor cells on response	february 2012

Trial Locations

Locations (1)

Centre Leon Berard; 🇫🇷 Lyon, France