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CECOG/BC1.2.001 – International Clinical Trials Workshop, July 1–2, Cluj-Napoca

CECOG/BC1.2.001 – International Clinical Trials Workshop, July 1–2, Cluj-Napoca CECOG News memo (2011) Vol. 4: 64–65 DOI 10.1007/s12254-011-0271-6 © Springer-Verlag 2011 Printed in Austria CECOG/BC1.2.001 A phase II study evaluating the effi cacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients pretreated with chemotherapy or hormonal treatment in combination with lapatinib for metastatic disease Coordinating Investigator: Prof Istvan Lang, National Institute of Oncology, Budapest, Hungary Sponsor: CECOG (Central European Cooperative Oncology Group) Trial Coordinators: Univ. Prof. Dr. Christoph Zielinski, Univ. Prof. Dr. Thomas Brodowicz Study period Study design First patient in: 25 October 2010 • Multicenter phase II single arm study Duration of recruitment: 12 months • Enrollment: approximately 30 ErbB2 positive metastatic breast cancer patients Follow up phase: 6 months after the last patient • Effi cacy and safety data will be collected completed the Adverse Event Follow up Visit • Investigators will assess response to treatment before every other cycle based on imaging • Following permanent treatment cessation, patients will be followed-up for survival. Dosung schedule Lapatinib 1250mg orally once daily continuously Vinorelbine 20 mg/m2 intravenously once weekly (days 1 Main criteria for inclusion and exclusion (extracts) and 8) for 2 weeks, followed by a rest week in a 3 week http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png memo - Magazine of European Medical Oncology Springer Journals

CECOG/BC1.2.001 – International Clinical Trials Workshop, July 1–2, Cluj-Napoca

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Publisher
Springer Journals
Copyright
Copyright © 2011 by Springer-Verlag
Subject
Medicine & Public Health; Medicine/Public Health, general; Oncology
ISSN
1865-5041
eISSN
1865-5076
DOI
10.1007/s12254-011-0271-6
Publisher site
See Article on Publisher Site

Abstract

CECOG News memo (2011) Vol. 4: 64–65 DOI 10.1007/s12254-011-0271-6 © Springer-Verlag 2011 Printed in Austria CECOG/BC1.2.001 A phase II study evaluating the effi cacy and safety of lapatinib + vinorelbine in ErbB2 positive metastatic breast cancer patients pretreated with chemotherapy or hormonal treatment in combination with lapatinib for metastatic disease Coordinating Investigator: Prof Istvan Lang, National Institute of Oncology, Budapest, Hungary Sponsor: CECOG (Central European Cooperative Oncology Group) Trial Coordinators: Univ. Prof. Dr. Christoph Zielinski, Univ. Prof. Dr. Thomas Brodowicz Study period Study design First patient in: 25 October 2010 • Multicenter phase II single arm study Duration of recruitment: 12 months • Enrollment: approximately 30 ErbB2 positive metastatic breast cancer patients Follow up phase: 6 months after the last patient • Effi cacy and safety data will be collected completed the Adverse Event Follow up Visit • Investigators will assess response to treatment before every other cycle based on imaging • Following permanent treatment cessation, patients will be followed-up for survival. Dosung schedule Lapatinib 1250mg orally once daily continuously Vinorelbine 20 mg/m2 intravenously once weekly (days 1 Main criteria for inclusion and exclusion (extracts) and 8) for 2 weeks, followed by a rest week in a 3 week

Journal

memo - Magazine of European Medical OncologySpringer Journals

Published: Jun 30, 2011

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