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:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT00201435
Eligibility Criteria:
Inclusion Criteria: Morphologically proven breast carcinoma
Written informed patient consent Measurable and/or evaluable disease Measurable disease is defined as least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.
Evaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can be evaluated for response according to the WHO-criteria for reporting on response in bone metastases.
Age 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months Adequate cardiac functions
Adequate hematological, renal and hepatic functions, defined as:
White blood cell count \> 3.9 x 109/L Trombocytes \> 100 x 109/L Serum creatinine \< 1.25 x ULN\* Bilirubin \< 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT \< 3.5 ULN ASAT \< 3.5 ULN If alkaline phosphatases (ALP) is \> 2.5 ULN ALAT \< 1.5 ULN ASAT \< 1.5 ULN
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Exclusion Criteria: Recurrence-free interval less than one year, if previous adjuvant or neoadjuvant regimen contained a taxane
Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years
Pregnancy or lactation
Known brain metastases
Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)
Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens
History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil)
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporine or vitamin K
Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
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Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00201435
Study Brief:
Protocol Section:
NCT00201435