Phase II, open-label trial of lapatinib and vinorelbine in women with previously treated human epidermal growth factor receptor 2 (HER2/neu) positive metastatic breast cancer to assess progression-free survival.

Breast Cancer Research Centre of WA0 sites19 target enrollmentApril 29, 2010

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Breast Cancer Research Centre of WA
Enrollment: 19
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 29, 2010

End Date

October 3, 2012

Last Updated

5 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

Breast Cancer Research Centre of WA

Eligibility Criteria

Inclusion Criteria

•Electrocardiogram (ECG) with QTc interval less than or equal to 480 msecs .

Exclusion Criteria

•Subjects meeting any of the following History of allergic or hypersensitivity reactions to either study drug (or related compounds) or their excipients.
•Females who are pregnant or continuing to breast\-feed.
•Subjects who have received more than 2 different types of treatment with a Her2/neu targeted therapy for metastatic breast cancer
•Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior anti\-cancer therapy that would, in the investigators judgment, make the subject inappropriate for this study .
•Any serious psychiatric disorder, dementia or altered mental status that would interfere with the subject’s safety or compliance to the study procedures.
•GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn’s, ulcerative colitis).
•Current active hepatic or biliary disease (with exception of subjects with Gilbert’s syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
•Active cardiac disease
•Concurrent therapy given to treat cancer including treatment with hormonal therapy, an investigational agent or concurrent participation in another clinical trial involving anti\-cancer investigational drug.
•Administration of an investigational drug within 30 days or 5 half\-lives, whichever is longer, preceding the first dose of study treatment.