None listed
Conditions
Interventions
VINORELBINA Type of group
Vinorelbine will be administered at a dose of 30 mg / m2 on days 1 and 8 thereof in an infusion of 6-10 minutes.
Group name:vinorelbine / gentamicin Type of group
Vinorelbine will be administered at a dose of 30 mg / m2 on days 1 and 8 thereof in an infusion of 6-10 minutes.
Gemcitabine will be administered after vinorelbine at a dose of 1200 mg / m in a 30-minute infusion.
Sponsors
ELI LILLY INTERAMERICA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: [1] Patients with stage IV breast carcinoma or histologically confirmed disseminated disease (the primary tumor), with evaluable disease. [2] Histological or cytological diagnosis of breast cancer, with evidence of metastatic disease. The lesions will not be susceptible to curative treatment through surgery and / or radiotherapy. [3] Women over 18 years old. [4] Previous chemotherapy with anthracyclines and taxanes. [5] Having received a maximum of two previous treatments with chemotherapy for the disseminated disease [6] Prior radiotherapy will be authorized, as long as the irradiated area does not constitutes the only disease documentation.
Exclusion criteria
Exclusion criteria: [1] Active infection or serious concomitant disease (at the investigator´s discretion). [2] Clinical evidence of metastasis in the central nervous system (CNS). [3] Blastic bony lesions as the only documentation of disease. [4] Previous neurological toxicity grade 3-4. [5] Previous treatment with gemcitabine and / or vinorelbine. [6] More than two previous treatments with chemotherapy for metastatic disease. [7] Altered liver function (bilirubin> 2.0 times above normal value); ALT and AST> 2.5 times higher than the normal range. ALT and AST can be raised 5 times above the normal value in patients with known liver metastases. [8] Inadequate renal function (creatinine> 2.0 mg / dL). [9] Pregnancy or lactation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A) Physical examination. B) Chest x-ray. C) TCyRMN. D) Ultrasound. E) Cytology and histology. Measure:The main endpoint is time elapsed until the progression of the disease. Timepoints:30 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be evaluated until progressive disease is documented or until unacceptable toxicity appears. The treatment will be suspended if the responsible doctor considers it appropriate or the patient requests it. Measure:Duration of survival, and of response, measurable tumor disease and toxicity. Timepoints:30 day | — |
Countries
Peru
Outcome results
None listed