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Cancer Investigation Volume 28, 2010 - Issue 9
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ORIGINAL ARTICLEClinical Translational Therapeutics

A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

Denise A. YardleySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Michael McCleodSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Fred SchreiberSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
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Patrick MurphySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
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Jeffrey PattonSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
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Dana S. ThompsonSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Mythili ShastrySarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Mark RubinSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Marianne MelnikSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
,
Howard A. BurrisSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
&
John D. HainsworthSarah Cannon Research Institute, Nashville, Tennesee, USA, Tennessee Oncology, PLLC, Nashville, Tennesee, USA, Florida Cancer Specialists, Fort Myers, Florida, USA, Watson Clinic, Lakeland, Florida, USA, Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, USA
 show all
Pages 925-931 | Published online: 06 Aug 2010
 
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ABSTRACT

We investigated the microtubulin inhibitor vinflunine—with trastuzumab in human epidermal growth factor receptor-2 (HER2)-positive patients—as first-line metastatic breast cancer therapy. HER2-negative patients received vinflunine on day 1; HER2-positive patients received vinflunine/trastuzumab every 21 days. Forty-eight patients in each treatment group were planned; the sponsor terminated the study early. Thirty-two evaluable patients (vinflunine, 11; vinflunine/trastuzumab, 21) were enrolled. In HER2-positive patients, vinflunine/trastuzumab produced an objective response rate (33%), clinical benefit rate (71%), and progression-free survival (6.2 months). Grade-3/4 neutropenia occurred in 14 (44%) patients; gastrointestinal toxicities were common and six patients were hospitalized for treatment-related toxicity. The vinflunine/trastuzumab combination was active and well tolerated, but our results do not suggest advantages over taxane/trastuzumab or vinorelbine/trastuzumab.

APPENDIX

Sarah Cannon Research Consortium participating sites

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