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Status:

COMPLETED

Standard Versus Continuous Capecitabine in Advanced Breast Cancer

Lead Sponsor:

Hospital San Carlos, Madrid

Collaborating Sponsors:

Complexo Hospitalario Universitario de A Coruña

Conditions:

Metastatic Breast Cancer

Eligibility:

FEMALE

18-75 years

Phase:

PHASE2

PHASE3

Brief Summary

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients...

Detailed Description

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Patients diagnosed with metastatic breast cancer
  • Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
  • The patient is ambulatory with a functional ECOG \< 2 status (see Appendix 2).
  • Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
  • Patients with a life expectancy of at least 3 months.
  • Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.
  • Exclusion criteria:
  • Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
  • Patients previously treated with capecitabine.
  • Patients with organ transplants.
  • Other diseases or severe affections:
  • Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.
  • Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
  • Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.
  • Severe renal impairment (baseline creatinine clearance \< 30 ml/min)
  • Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.
  • Patients with an active infection.
  • Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.
  • Patients showing the following laboratory values:
  • Neutrophil count \< 555 x 109/l
  • Platelet count\< 100 x 109/l
  • Serum creatinine \> 1,5 x upper normality limit
  • seric bilirubin \> 2,0 x upper normality limit
  • ALAT, ASAT \> 2,5 x upper normality limit or \> 5 x upper normality limit in case of liver metastases
  • Alkaline phosphatase \> 2,5 x upper normality limit \> 5 x upper normality limit in case of liver metastases o \> 10 x upper normality limit in case of bone metastases.
  • Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.
  • Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
  • Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
  • Patients who have received more than two cycles of chemotherapy for the metastatic disease.
  • Patients Her2 + per FISH ó +++ Immunohistochemistry

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2015

    Estimated Enrollment :

    195 Patients enrolled

    Trial Details

    Trial ID

    NCT00418028

    Start Date

    September 1 2005

    End Date

    January 1 2015

    Last Update

    February 22 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Hospital Clinico San Carlos

    Madrid, Spain, 28040