Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

Exclusion Criteria

• •1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
• •2. known secondary malignancy requiring therapy
• •3. active infectious disease
• •4. brain metastases requiring therapy
• •5. neuropathy grade 2 or above
• •6. absolute neutrophil count less than 1,500/mm3
• •7. platelet count less than 100,000/mm3
• •8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
• •9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
• •10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
• •11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
• •12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
• •13. radiotherapy to breast and thorax region within the past four weeks prior to treatment with the trial drug or during the trial
• •14. women who are sexually active and unwilling to use a medically acceptable method of contraception
• •15. pregnancy or lactation
• •16. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
• •17. patients unable to comply with the protocol