Breast Cancer
Conditions
Keywords
breast cancer
Brief summary
Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine. Aim of the study is to assess the optimal dosage and safety in this setting.
Interventions
DRUGGemcitabine
A: second line therapy - 1000 mg/m2, IV, day 1 and day 8 q 21 days until disease progression B: 1000 mg/m2, IV, day 1 and day 8 q 21 days, until treatment failure
DRUGdocetaxel
A: 80 mg/m2, IV, q 21 days until treatment failure followed by second line single agent gemcitabine B: 80 mg/m2, IV, q 21 days until treatment failure
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* histologically verified diagnosis of breast carcinoma, at first diagnosis * restricted previous adjuvant chemotherapy (completed \>6 months prior the study) * measurable and/or non-measurable disease * previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated * performance status 0-2 (WHO, Zubrod) * adequate bone marrow reserve defined * adequate liver / renal functions defined
Exclusion criteria
* any prior systematic chemotherapy for metastatic breast cancer * expected survival time less than 12 weeks * past or current history of malignant neoplasm other than breast carcinoma * except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri * known brain metastases/leptomeningeal involvement * active uncontrolled infection * symptomatic peripheral neuropathy \> grade 2 according to NCI * patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease * concomitant illness that is contraindication to the use of corticosteroids * other concomitant serious illness or medical condition, which may worsen due to the treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to treatment failure (TTTF) | baseline to stopping treatment |
Secondary
| Measure | Time frame |
|---|---|
| Response rate | baseline to measured progressive disease |
| Duration of response | time of response to progressive disease |
| Overall survival | baseline to date of death from any cause |
| Time to progressive disease | baseline to measured progressive disease |
Countries
Finland
Outcome results
None listed