Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT00418028
Eligibility Criteria:
Inclusion Criteria
1. Patients diagnosed with metastatic breast cancer
2. Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
3. The patient is ambulatory with a functional ECOG \< 2 status (see Appendix 2).
4. Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
5. Patients with a life expectancy of at least 3 months.
6. Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.
Exclusion criteria:
1. Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
2. Patients previously treated with capecitabine.
3. Patients with organ transplants.
4. Other diseases or severe affections:
1. 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.
2. Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
3. 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.
4. Severe renal impairment (baseline creatinine clearance \< 30 ml/min)
5. 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.
6. Patients with an active infection.
7. 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.
8. Patients showing the following laboratory values:
1. Neutrophil count \< 555 x 109/l
2. Platelet count\< 100 x 109/l
3. Serum creatinine \> 1,5 x upper normality limit
4. seric bilirubin \> 2,0 x upper normality limit
5. ALAT, ASAT \> 2,5 x upper normality limit or \> 5 x upper normality limit in case of liver metastases
6. 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.
9. 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.
10. Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
11. Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
12. Patients who have received more than two cycles of chemotherapy for the metastatic disease.
13. Patients Her2 + per FISH รณ +++ Immunohistochemistry
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00418028
Study Brief:
Protocol Section:
NCT00418028