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VinoMetro: Phase II study of metronomic daily oral vinorelbine as first-line chemotherapy in advanced/metastatic hormone receptor positive (HR+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer resistant to endocrine therapy

Date

11 Sep 2017

Session

Poster display session

Presenters

Tanja Elger

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

T. Elger1, T. Decker2, T. Fehm3, S. Fuxius4, N. Harbeck5, I. Juhasz-Böss6, V. Möbus7, C. Thomssen8, M. Seehase9, L. Schollenberger10, C. Ruckes10, M. Schmidt9

Author affiliations

  • 1 Klinik Und Poliklinik Für Geburtshilfe Und Frauengesundheit, Universitätsmedizin Mainz, 55131 - Mainz/DE
  • 2 ,, Schwerpunktpraxis für Hämatologie und Onkologie, Ravensburg/DE
  • 3 Frauenklinik, Universitätsklinikum Düsseldorf, Düsseldorf/DE
  • 4 ,, Onkologische Schwerpunktpraxis, Heidelberg/DE
  • 5 Brustzentrum, Klinikum der Ludwig-Maximilians-Universität, Munich/DE
  • 6 Klinik Für Frauenheilkunde, Geburtshilfe Und Reproduktionsmedizin, Universitätsklinikum des Saarlandes, Homburg/DE
  • 7 Klinik Für Gynäkologie Und Geburtshilfe, Klinikum Frankfurt Höchst, Frankfurt/DE
  • 8 Klinik Und Poliklinik Für Gynäkologie, Universitätsklinikum Halle, Halle (Saale)/DE
  • 9 Klinik Und Poliklinik Für Geburtshilfe Und Frauengesundheit, Universitätsmedizin Mainz, Mainz/DE
  • 10 Interdisziplinäres Zentrum Klinische Studien (izks), Universitätsmedizin Mainz, Mainz/DE
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Background

Chemotherapy (CTx) is a cornerstone in HR+/HER2- advanced/metastatic breast cancer (a/mBC) after endocrine failure. In this indication, vinorelbine (VRL) is a well-established cytotoxic drug. There is a high medical need for new options that prolong the time between endocrine failure and intensive CTx, which is commonly associated with impaired quality of life and serious side effects. Metronomic CTx was shown to induce disease control in a/mBC with a favorable safety profile. This innovative approach involving continuous daily dosing of oral VRL, which could provide anti-angiogenic and immune-modulatory properties, has not been investigated so far in this indication.

Trial design

VinoMetro is an open-label, single-arm, phase II study (Simon two-stage minimax) of metronomic daily oral VRL (30 mg/day) as first-line CTx. The study involves strict safety monitoring with an initial safety run-in. It is accompanied by a steering committee and supervised by an independent monitoring board. The main objectives are to estimate efficacy in terms of clinical benefit rate after 24 weeks of treatment (primary endpoint) and the progression-free survival, amongst others, as well as the assessment of safety and quality of life. Patients with HR+/HER2- a/mBC having failed or being no candidate for endocrine therapy (targeted combinations allowed) and being naïve to palliative CTx are eligible, if they exhibit ECOG 0-1. The main exclusion criteria are prior vinca-alkaloids, aggressive disease requiring combination CTx and CNS involvement. Until 2017-04-30, 5 patients were enrolled. It is planned to include 45 (39 evaluable) patients at 8 German sites until 09/2018. Scheduled completion date is 09/2019. Two interim analyses are planned (first analysis: safety evaluation based on the 10 initial patients with predefined stopping rules). VinoMetro is an investigator initiated trial (NCT03007992) sponsored by the University Medical Centre of Johannes Gutenberg-University Mainz, Germany, and supported by an unrestricted grant provided by Pierre Fabre Pharma GmbH (Freiburg, Germany).

Clinical trial identification

EudraCT 2016-000284-17

Legal entity responsible for the study

University Medical Centre of Johannes Gutenberg-University Mainz, Germany

Funding

Pierre Fabre Pharma GmbH, Freiburg, Germany

Disclosure

T. Elger, M. Seehase, L. Schollenberger, C. Ruckes, M. Schmidt: Unrestricted study grant for VinoMetro provided by Pierre Fabre Pharma GmbH (Freiburg, Germany). All other authors have declared no conflicts of interest.

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