C50 Cancer de mama
Conditions
Interventions
None listed
Sponsors
SOCIEDAD LATINOAMERICANA Y DEL CARIBE DE ONCOLOGIA CLINICA (SLACOM)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients • Obtaining informed consent • Metastatic Breast Cancer • measurable or non-measurable disease according to RECIST criteria • Confirmation of breast cancer by pathological study • Without limitation as to the amount of prior chemotherapy regimens allowed for metastatic disease • elapsed period of at least 3 weeks since prior chemotherapy. the Patients must have recovered from all acute toxicity caused by such therapy (excluding alopecia). • Age 18 • ECOG 0-2 • Absolute neutrophil count (ANC) 1.0; hemoglobin 9 platelets 75.000 • AST, ALT and alkaline phosphatase 50 ml / min • If women with reproductive capacity, the pregnancy test should to negative and the patient should agree to use a method contraception to avoid pregnancy during the study.
Exclusion criteria
Exclusion criteria: • Overexpression and / or amplification of HER2, as determined by the Immunohistochemistry (3 +) and FISH (> 2.0) • There should have been used fluoropyrimidine in cases of metastasis. It allows adjuvant fluoropyrimidine if it has been> 12 months from the treatment. • No restriction on previous hormonal therapies • gastrointestinal malabsorption syndrome that could prevent the absorption of drug orally • Not recommended for concurrent use of warfarin, because interactions between drugs may hinder the management of international normalized ratio (INR, for its acronym in English). • metastasis is allowed in the central nervous system if it has been previously or is clinically stable for at least 3 months. • Patients who are pregnant or breastfeeding • Life expectancy <3 months
Countries
Argentina, Mexico, Peru, United States
Outcome results
None listed