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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00128856
Eligibility Criteria:
Inclusion Criteria:
* Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
* Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
* Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
* Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
* At least a 6 month life expectancy.
* Neutrophils \> 1500; platelets \> 100000; haemoglobin \> 10 mg/dL.
* Adequate renal and hepatic functions, with serum creatinine \< 1.2 mg/dl and total bilirubin \< 2 mg/dl.
* Adequate contraceptive methods during the study and up to 3 months after.
* Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction \> 55%.
Exclusion Criteria:
* Inflammatory carcinoma or stage I, II or IV breast cancer disease.
* Males.
* Active infection.
* Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
* Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
* Pre-existing motor or sensorial neuropathy \> grade 1.
* Inability for treatment compliance.
* History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
* History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
* History of myocardial infarction in the previous 6 months.
* Hypertension not controlled.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00128856
Study Brief:
Protocol Section:
NCT00128856