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Spots Global Cancer Trial Database for Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects

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Trial Identification

Brief Title: Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects

Official Title: A Phase II, Single-Arm, Multi-Center Study Evaluating the Combination of Vinorelbine and Lapatinib in Women With ErbB2 Overexpressing Metastatic Breast Cancer

Study ID: NCT00709618

Study Description

Brief Summary: This is an open-label, single-arm, multi-center, Phase II study to determine the activity of vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study. Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease progression or withdrawal from the study. The primary objective of this study is to evaluate overall tumor response rate of lapatinib in combination with vinorelbine. Secondary objectives include progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments will be performed at 4, 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib, Vinorelbine

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

GSK Investigational Site, Muscle Shoals, Alabama, United States

GSK Investigational Site, Tucson, Arizona, United States

GSK Investigational Site, Sacramento, California, United States

GSK Investigational Site, Jacksonville, Florida, United States

GSK Investigational Site, Plantation, Florida, United States

GSK Investigational Site, Augusta, Georgia, United States

GSK Investigational Site, Cedar Rapids, Iowa, United States

GSK Investigational Site, Baltimore, Maryland, United States

GSK Investigational Site, Bethesda, Maryland, United States

GSK Investigational Site, Jackson, Mississippi, United States

GSK Investigational Site, Kansas City, Missouri, United States

GSK Investigational Site, St. Louis, Missouri, United States

GSK Investigational Site, Omaha, Nebraska, United States

GSK Investigational Site, New York, New York, United States

GSK Investigational Site, Greensboro, North Carolina, United States

GSK Investigational Site, Columbus, Ohio, United States

GSK Investigational Site, Oklahoma City, Oklahoma, United States

GSK Investigational Site, Tulsa, Oklahoma, United States

GSK Investigational Site, Eugene, Oregon, United States

GSK Investigational Site, Portland, Oregon, United States

GSK Investigational Site, Philadelphia, Pennsylvania, United States

GSK Investigational Site, Memphis, Tennessee, United States

Contact Details

Name: GSK Clinical Trials

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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