gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

Sorafenib (BAY 43-9006) in patients with metastatic breast cancer - a Phase II multicentre open trial

Meeting Abstract

  • corresponding author presenting/speaker Sibylle Loibl - Universitätsfrauenklinik Frankfurt/M, Deutschland
  • Giulia Bianchi - Istituto Nazionale Tumori, Milano, Italy
  • Claudio Zamagni - Policlinico S. Orsola Malpighi, Divisone onologica Medica, Bologna, Italy
  • Andrea Ardizzoni - Azienda Ospedaliera, Oncologia Medica A, Parma, Italy
  • Guenter Raab - Marienhospital, Frauenheilkunde und Geburtshilfe, Stuttgart, Germany
  • Salvatore Siena - Azienda Ospedaliera Niguarda, Divisione Oncologia Medica, Milano, Italy
  • Christopher Wolf - Frauenklinik vom Roten Kreuz, Gynäkologische and Geburtshilfe, München, Germany
  • Torsten Westermeier - Bayer Vital GmbH, Leverkusen, Germany
  • Loredana Bergamini - Bayer S.p.A., Milano, Italy
  • Lucca Gianni - Istituto Nazionale Tumori, Milano, Italy
  • Manfred Kaufmann - Universitätsfrauenklinik Frankfurt/M

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO032

The electronic version of this article is the complete one and can be found online at:

Published: March 20, 2006

© 2006 Loibl et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background: Sorafenib (BAY 43–9006) is a novel, oral multi-kinase inhibitor that targets the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGFR-2 and PDGFR-β, thereby affecting the tumour and vasculature. In Phase I trials, single-agent sorafenib showed preliminary anti-tumour activity in patients with metastatic breast cancer. This multicentre, Phase II, open-label, single-arm study was designed to assess WHO-defined best overall response rate in patients with metastatic breast cancer, and investigate breast cancer biomarkers predicting for sorafenib sensitivity.

Patients and methods: 54 patients (ECOG PS 0–2) who had received at least one prior chemotherapy for metastatic breast cancer, and failed at least one adjuvant hormonal therapy if ER/PgR positive, and failed trastuzumab therapy if HER2 positive, received continuous oral sorafenib 400 mg bid. Patients had received between 1 and 11 prior chemotherapy regimens, and 64% received at least four prior chemotherapy treatments. The primary endpoint of the study was overall response rate. Other endpoints included time to progression (TTP), time to response, duration of response, and survival. Baseline markers in the tumour (pERK, VEGFR, HER-2, ER, PgR) and in the blood (serum EGFR, serum VEGF, serum uPA, plasma PAI-1) were collected to conduct pharmacodynamic studies. Adverse events (AEs) were graded by CTCAE v3.0.

Results: Of the 50 patients evaluable for response, one (1.9%) had a partial response, and 19 (35.2%) had stable disease. The overall median TTP was 55.5 days (range 0–280). The most common drug-related AEs were rash/desquamation (31.5% of patients), anorexia (27.8%), hand–foot skin reaction (HFS: 22.2%), pruritus (22.2%), and diarrhoea (18.5%). Frequent grade 3 events included rash/desquamation (5.6% of patients), fatigue and HFS (both 3.7%). Three patients withdrew due to AEs, 42 due to progressive disease, and two patients died during the study. Five patients are still undergoing treatment.

Conclusions: Sorafenib monotherapy was well tolerated in this group of heavily pretreated patients. Prolonged stabilization of disease was observed in a few patients, and its association with specific tumour and/or circulating biomarkers is being investigated. Combination studies of sorafenib in breast cancer are planned.