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Vandetanib with docetaxel as second-line treatment for advanced breast cancer: a double-blind, placebo-controlled, randomized Phase II study

  • PHASE II STUDIES
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Summary

Purpose The aim of this Phase II study was to assess the efficacy and safety of vandetanib in combination with docetaxel in patients with pretreated advanced breast cancer. Methods The primary study objective was to compare the number of progression events in patients receiving once-daily oral vandetanib (100 mg) in combination with docetaxel (100 mg/m2 iv every 21 days) versus placebo plus docetaxel. Sixty-four patients were randomized to receive study treatment (n = 35, vandetanib; n = 29, placebo). Results A slightly greater number of patients had experienced a progression event by the data cut-off in the vandetanib group (24 [69%]) compared with the placebo group (18 [62%]); HR = 1.19, two-sided 80% CI: 0.79–1.81; two-sided P = 0.59), suggesting that the addition of vandetanib to docetaxel did not affect the risk of disease progression compared with placebo plus docetaxel. The safety and tolerability profile of the combination therapy reflected those of both drugs as monotherapy agents. Conclusions In patients with advanced breast cancer, vandetanib plus docetaxel was generally well tolerated. Clinical benefit was not different to that observed with placebo plus docetaxel. However, due to the small patient number it was not possible to yield robust results, further research is required to identify predictive factors for patient selection.

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Acknowledgements

This study, including editorial assistance provided by Chris Watson of Mudskipper Bioscience, was supported financially by AstraZeneca.

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Authors and Affiliations

  1. Medical Oncology Department, St John Hospital, Bécsi út 132, 1032, Budapest, Hungary

    Katalin Boér

  2. National Institute of Oncology, Budapest, Hungary

    István Láng

  3. Medical Oncology Department, Hospital Universitario Arnau de Vilanova, Lleida, Spain

    Antonio Llombart-Cussac

  4. Onkologkliniken, Centrallasarettet, Västerås, Sweden

    Inger Andreasson

  5. Hospital de Cruces, Plaza de Cruces, Bizkaia, Spain

    Guillermo L. Vivanco

  6. AstraZeneca, Loughborough, UK

    Nick Sanders

  7. AstraZeneca, Macclesfield, UK

    Gillian M. Pover

  8. New Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa

    Elizabeth Murray

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  1. Katalin Boér
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Correspondence to Katalin Boér.

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Boér, K., Láng, I., Llombart-Cussac, A. et al. Vandetanib with docetaxel as second-line treatment for advanced breast cancer: a double-blind, placebo-controlled, randomized Phase II study. Invest New Drugs 30, 681–687 (2012). https://doi.org/10.1007/s10637-010-9538-8

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  • DOI: https://doi.org/10.1007/s10637-010-9538-8

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