Metastatic Breast Cancer
Conditions
Keywords
gemcitabine, vinorelbine, cisplatin, capecitabine, pretreated metastatic breast cancer
Brief summary
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. For each randomisation arm, 47 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective. Study Design: Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
Interventions
DRUGgemcitabine
DRUGcisplatin
DRUGvinorelbine
DRUGcapecitabine
Sponsors
Ludwig-Maximilians - University of Munich
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 confirmed metastatic breast cancer * All patients were required to give written informed consent * Only one prior chemotherapy for metastatic breast cancer was allowed. This clinical trial was designed to test the efficacy of a second-line chemotherapy. * Antracycline-pretreatment during aduvant or palliative first line therapy * Bidimensionally measurable lesion outside a previous radiation field. * Age \>= 18 years * Karnofsky Performance status \>= 70% * Adequate heamatological, renal, cardiac and hepatic function * No radiation of the measurable lesion during the study was allowed.
Exclusion criteria
* Only bone metastases * Active infection * Previous treatment with one of the study drugs * Application of other cytotoxic chemotherapy * Insufficent renal function (creatinine clearance \< 60ml/min) * Known DPD deficiency * clinically unstable brain metastasis * pregancy or lactation * other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | one year after last patient in |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | one year after last patient in |
| Overall Survival | one year after last patient in |
| Toxicity | — |
Outcome results
None listed