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:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01291667
Eligibility Criteria:
Inclusion Criteria:
* signed ICF
* pathologic diagnosis breast cancer
* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS\>=70
Exclusion Criteria:
* More than three prior chemotherapy lines for advanced disease LVEF\<50%
* prior exposure vinorebine for breast cancer
* prior exposure Trastuzumab for breast cancer
* uncontrolled brain metastasis
* breastfeeding or pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01291667
Study Brief:
Protocol Section:
NCT01291667