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 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT00668616
Eligibility Criteria:
Inclusion Criteria:
* women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0)
* ECOG performance status 0-1
* start of adjuvant therapy not later than 4 weeks after surgery
* hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l
* normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value
* normal kidney function as defined by: creatine till 1.5 x normal value
* negative pregnancy test for patients before menopause and effective contraception
* written informed consent
Exclusion Criteria:
* prior radiation, chemotherapy, hormontherapy and immunotherapy
* patients with more than 3 afflicted lymph nodes
* afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes
* bilateral breast cancer or second carcinoma of the breast
* inflammatory breast cancer and/or distant metastases
* existing clinically relevant peripheral neuropathie
* heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II
* patients with active infections and/or not controlled hypercalcemia
* pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00668616
Study Brief:
Protocol Section:
NCT00668616