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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02433067
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 to 85 years
* First breast cancer HER2 + histologically confirmed,
* WHO grade Performance Index ≤1
* Normal renal function (creatinine clearance ≥ 60 ml min-1)
* Normal heart function with LVEF ≥ 50%
* Normal liver function (AST and ALT normal)
* Physical activity certificate issued by a cardiologist or an oncologist,
* Active contraception or postmenopausal
Exclusion Criteria:
* Patients aged under 18 and over 85
* Patients having no breast cancer HER2+
* Patients with metastases
* Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
* Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
* Symptomatic osteoarthritis,
* Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
* Patients suffering from malnutrition (Body Mass Index (BMI) \<18 kg m-2) or weight loss of over 10% during the last 3 months,
* Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
* Pregnant or lactating Patients.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02433067
Study Brief:
Protocol Section:
NCT02433067