NCT00754702

Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital of Crete · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of metronomic oral vinorelbine taken three times a week plus daily lapatinib without break, as salvage treatment in patients with metastatic breast cancer.

Detailed description

Continuous administration of oral vinorelbine, given three times a week (metronomic) is feasible and exceptionally well tolerated at doses up to 50 mg. Early results show activity against refractory tumors and provide evidence towards clinical proof of efficacy for metronomic chemotherapy. Recently, lapatinib plus capecitabine was proven superior to capecitabine alone in women with HER2-positive advanced breast cancer that has progressed after treatment with regimens that included an anthracycline, a taxane, and trastuzumab.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Vinorelbine	Vinorelbine p.o (50 mg 3 times a week) until disease progression or appearance of unacceptable toxicity
DRUG	Lapatinib	Lapatinib p.o every day without interruption disease progression or appearance of unacceptable toxicity

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-09-18
• Last updated: 2015-09-28

Locations

2 sites across 1 country: Greece