Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

Inclusion criteria

• female patients aged 18 years or older
• patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
• patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
• measurable tumour deposits by one or more radiological techniques (MRI, CT)
• life expectancy of at least 6 months
• Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
• patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion criteria

• hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
• known secondary malignancy requiring therapy
• active infectious disease
• brain metastases requiring therapy
• neuropathy common toxicity criteria (CTC) grade 2 or above
• absolute neutrophil count less than 1,500/mm3
• platelet count less than 100,000/mm3
• bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
• aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
• serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
• concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
• chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
• radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
• women who are sexually active and unwilling to use a medically acceptable method of contraception
• pregnancy or lactation
• 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)
• patients unable to comply with the protocol