Inclusion Criteria:

Morphologically proven breast carcinoma

Written informed patient consent Measurable and/or evaluable disease Measurable disease is
defined as least one lesion that can be accurately measured in at least one dimension as
≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section
8.

Evaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can
be evaluated for response according to the WHO-criteria for reporting on response in bone
metastases.

Age 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months
Adequate cardiac functions

Adequate hematological, renal and hepatic functions, defined as:

White blood cell count > 3.9 x 109/L Trombocytes > 100 x 109/L Serum creatinine < 1.25 x
ULN* Bilirubin < 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT < 3.5 ULN ASAT <
3.5 ULN If alkaline phosphatases (ALP) is > 2.5 ULN ALAT < 1.5 ULN ASAT < 1.5 ULN

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Exclusion Criteria: Recurrence-free interval less than one year, if previous adjuvant or
neoadjuvant regimen contained a taxane

Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively
treated carcinoma in situ of the cervix, diagnosed during the past five years

Pregnancy or lactation

Known brain metastases

Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria
(severe paresthesia and/or mild weakness, or worse)

Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance
below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the
proposed regimens

History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on
previous treatment with fluorouracil)

Active infection or other serious underlying medical condition which would impair the
ability of the patient to receive protocol treatment, including prior allergic reactions
to drugs containing cremophor, such as teniposide, cyclosporine or vitamin K

Dementia or significantly altered mental status that would prohibit the understanding and
giving of informed consent.

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