EVALUATION OF RESPONSE TO TWO SCHEDULES OF CAPECITABINE IN PATIENTS WITH METASTATIC BREAST CANCER

Not Applicable

Recruiting

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-043-14
• Lead Sponsor: SOCIEDAD LATINOAMERICANA Y DEL CARIBE DE ONCOLOGIA CLINICA (SLACOM),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 0

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 <2.5 times the upper limit of what
Normal (or 5 times the upper limit of normal in the case of
liver) metastases. Total bilirubin <1.5 times the upper limit of
normal
• estimated creatinine clearance> 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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified