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Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study

Phase 2/Phase 3
18 Years
Not Enrolling
Breast Neoplasm

Thank you

Trial Information

Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study

Open labeled randomized multicentre phase II/III trial. It is intended to include patients
who are not usually included into clinical trials because they are not having disease with
measurable lesions. In breast cancer the bulk of patients with metastatic disease is
presenting with bone metastases which is difficult to evaluate with respect to response. In
this study it is one of the main objectives to include this kind of everyday patients that
we see in the clinic.

Because of this we will be using TTF as the primary endpoint. Skeletal events requiring
radiotherapy or major changes in pain medications are defined as treatment failures causing
stop in treatment even in the absence of radiological findings.

A: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14
q 3w

Patients are randomized equally between the two arms.

Concomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has
been initiated at least four weeks before study entry.

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

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

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


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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Principal Investigator

Erik Wist, MD, PhD

Investigator Role:

Principal Investigator


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

March 2005

Completion Date:

May 2008

Related Keywords:

  • Breast Neoplasm
  • Breast
  • Cancer
  • Paclitaxel
  • Docetaxel
  • Qulaity of life
  • Breast Neoplasms
  • Neoplasms