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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01548534
Eligibility Criteria:
Inclusion Criteria:
* Metastatic breast cancer requiring first-line taxanes or anthracyclines based chemotherapy
* HER2 negative, HR positive
* Life expectancy \> 3 months
* ECOG Performance Status \< or = 2 within 15 days before randomization
* Measurable and/or evaluable disease according to RECIST criteria 1.1
* Age \> or = 18 years and \< or = 80 years
* Body Mass Index (BMI)\>17 for patients \< 70 years and BMI\>21 for patients \> 70 years, within 15 days before randomization
* Hepatic parameters : total bilirubin strictly normal, AST and ALT \< or = 3xULN (5 if liver metastases) within 15 days before randomization
* Signed written informed consent
Exclusion Criteria:
* Triple negative breast cancer or HER2 over expression
* Symptomatic central nervous system metastases
* Previous chemotherapy for metastatic breast cancer
* Obesity with BMI \> 35 within 15 days before randomization
* Presence of another invasive cancer
* Uncontrolled Cardiac disease or uncontrolled hypertension
* Milk protein intolerance
* Known food allergy to fish
* Women of childbearing potential not using adequate contraceptive measures, pregnant or breast feeding.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01548534
Study Brief:
Protocol Section:
NCT01548534