Breast Neoplasm
Conditions
Keywords
Breast, Cancer, Paclitaxel, Docetaxel, Qulaity of life
Brief summary
We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.
Detailed description
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.
Interventions
DRUGPaclitaxel weekly in combination with capecitabine
DRUGDocetaxel every 3 week in combination with capecitabine
Sponsors
Norwegian Breast Cancer Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure | — |
| Quality of life | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | — |
| Response rates | — |
Countries
Norway
Outcome results
None listed