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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT00433095
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven, metastatic breats cancer.
* HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
* Written informed consent
* no previous therapy with vinorelbine or trastuzumab
* Age \* 18 and \* 75 years
* Karnofsky-Performance status \> 70%
* Life expectance 16 weeks and more
* Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions
* Exclusion of pregnancy and adequte contraception during childbearing age.
* Adequate hematological, renal, and hepatic function
* Normal cardiac function. LVEF should not be \>10% below normal.
* Adequate compliance to perform treatment and subsequent follow-up visits
Exclusion Criteria:
* Locoregional recurrence of breast cancer only or development of contralateral breast cancer
* Pregnancy or lactation
* Symptomatic brain- or meningeal metastasis
* Concurrent endocrine antitumor therapy
* Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
* Peripheral neuropathy \>= NCI CTC Grade 2.
* other severel disease which preclude adequate treatment
* Participation in a clinical trial within the last 30 days.
* Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00433095
Study Brief:
Protocol Section:
NCT00433095