RANDOMIZED PHASE III COMPARATIVE TRIAL OF VINORELBIN AGAINST THE ASSOCIATION OF GEMCITABIN AND VINORELBIN IN PATIENTS WITH ADVANCED BREAST CARCINOMA PREVIOUSLY TREATED WITH ANTRACYCLINICS AND TAXANES.
- Registration Number
- PER-049-03
- Lead Sponsor
- ELI LILLY INTERAMERICA INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
[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.
[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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A) Physical examination.<br>B) Chest x-ray.<br>C) TCyRMN.<br>D) Ultrasound.<br>E) Cytology and histology.<br>Measure:The main endpoint is time elapsed until the progression of the disease.<br>Timepoints:30 day<br>
- Secondary Outcome Measures
Name Time Method <br>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.<br>Measure:Duration of survival, and of response, measurable tumor disease and toxicity.<br>Timepoints:30 day<br>