Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

Sponsor
National Taiwan University Hospital
Study ID
NCT00912275
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib plus oral vinorelbine — DRUG
    Lapatinib -dose level -I, I, II, III 1000mg po daily;dose level IV:1250mg po daily; Oral vinorelbine at the dose level reached on days 1, and 8 of a 21 days cycle. Dose level -I:30mg/m2,I:40mg/m2,II:50mg/m2,III:60mg/m2,IV:60mg/m2,V:80mg/m2

Study Details

Phase I part: to determine the recommended dose, and observe the preliminary response and safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase II part: to determine the progression free survival, response rate, and to evaluate the safety profile of the combination of oral lapatinib with vinorelbine in patients with ErbB2 positive metastatic breast cancer. Phase I part has been completed. Phase II part is underway.

Key Dates

Start date
Nov 24, 2008
Status verified
May 2019
Primary completion
Mar 31, 2015
Completion
Jul 7, 2017

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib plus Oral Vinorelbine
    Oral vinorelbine on day 1 and day 8 q3w plus lapatinib 1000mg/day.

Primary Outcome Measure

To determine the recommended dose of the combination of oral lapatinib with vinorelbine (phase I part), and progression free survival (phase II part) [ Time Frame: phase I part: 4 months, phase II part: 1 and half years ]

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