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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04704856
Eligibility Criteria:
Inclusion Criteria:
* stage I-III breast cancer
* scheduled for neoadjuvant chemotherapy with 2 or 3-weekly Adriamycin/Cyclofosfamide, followed by Paclitaxel weekly +/- trastuzumab
* willing to undergo an additional ultrasound guided biopsy
* ECOG-performance score ≤ 2 (able to perform basic activities of daily living such as walking or biking)
Exclusion Criteria:
* addition of immuno- or targeted therapy at start of neoadjuvant chemotherapy
* currently participating in structured vigorous aerobic exercise and/or resistance exercise
(≥2 days per week).
* cognitive disorder or severe emotional instability
* presence of other disabling co-morbidity that might hamper physical exercise e.g. heart failure (NYHA classes 3 and 4), chronic obstructive pulmonary disease (COPD, gold 3 and 4), orthopaedic conditions and neurological disorders (e.g., hernia, paresis, amputation, active rheumatoid arthritis);
* immunosuppressive medication (e.g. corticosteroids (other than used as part of standard chemotherapy premedication protocol), cyclosporine)
* immunodeficiency (primary or secondary)
* impossibility to perform an ultrasound-guided biopsy of the tumor
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04704856
Study Brief:
Protocol Section:
NCT04704856