NCT01730677

Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab

Randomized Phase II Study of Lapatinib Plus Vinorelbine Versus Vinorelbine in Patients With HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib and Trastuzumab Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive metastatic breast cancer patients.

Detailed description

This study is a multicenter, randomized, open label, phase II study. Patients will be randomized to either lapatinib plus vinorelbine (LV) arm or vinorelbine alone (V) arm, if they are satisfied by inclusion and exclusion criteria. The stratification factors are followings: 1) visceral metastasis vs. others, 2) previous response to lapatinib treatment, complete response(CR)+partial response(PR) vs. stable disease(SD)≥ 12wks. Patients in LV arm will receive daily lapatinib 1,000mg with vinorelbine 20mg/m2 day1 and day 8. Patients in V arm will receive vinorelbine 30mg/m2 day 1 and day 8. Treatment repeats every 21 days unless there is any evidence of disease progression or unacceptable toxicity or noncompliance by patient with protocol requirements. Response will be documented by physical examination, chest or abdomen CT prior to treatment as a baseline, and every 2 cycles (window period ± 1 week) after a start of treatment and at 18 weeks.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Lapatinib	lapatinib 1000mg, once daily
DRUG	Vinorelbine	Vinorelbine 20mg/m2, D1 and D8, every 3 weeks

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2012-11-21
• Last updated: 2014-03-12

Locations

1 site across 1 country: South Korea