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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT01423695
Eligibility Criteria:
Inclusion Criteria:
* histologically confirmed metastatic breast cancer overexpressing HER2
* pretreatment with anthracycline in either the adjuvant or palliative setting.
* HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
* informed consent
Exclusion Criteria:
* more than 1 chemotherapy for advanced disease
* taxane or trastuzumab pretreatment
* brain metastases
* Eastern Cooperative Oncology Group (ECOG) performance status \>1
* pregnancy or lactation, childbearing potential without reliable contraception
* clinically significant cardiac disease,
* neutrophils \<1500/µl, platelets \<75,000/µl
* total bilirubin and creatinine \>1.5 × the upper limit of normal
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01423695
Study Brief:
Protocol Section:
NCT01423695