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

Sponsor
National Cancer Center, Korea
Study ID
NCT01730677
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    lapatinib 1000mg, once daily
  • Vinorelbine — DRUG
    Vinorelbine 20mg/m2, D1 and D8, every 3 weeks

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Mar 2014
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib+Vinorelbine
    lapatinib 1000mg, once daily vinorelbine 20mg/m2, D1 and D8, every 3 weeks
  • No Intervention: Vinorelbine
    vinorelbine 30mg/m2, D1 and D8, every 3 weeks

Primary Outcome Measure

Progression free survival rate at 18 weeks [ Time Frame: The time point of 18 weeks from the initiation of study treatment. ]

Central Contacts

Related Studies