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Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer

NCT00912275 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2019-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

lapatinib plus oral vinorelbine

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

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yen-Shen Lu, M.D.,Ph.D · Department of Oncology,National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-24
Primary Completion
2015-03-31
Completion
2017-07-07

Countries

  • Taiwan

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912275 on ClinicalTrials.gov