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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT04790266
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent must be obtained before any assessment is performed
2. Age ≥ 18 years at visit 1
3. Performance status ECOG 0-1
4. \*Stage I-III histology proven breast cancer
5. Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
6. Negative pregnancy test (plasma HCG) for all females of childbearing potential (i.e not permanently sterilised- post hysterectomy or tubal ligation status) In the ancillary study patients with stage 0 (DCIS) histology proven breast cancer will also be included.
Exclusion Criteria:
1. Known metastatic spread of any cancer
2. Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
3. Renal function decrease (eGFR \< 30 ml/min)
4. Known coronary artery disease
5. Angina pectoris
6. Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit
7. Patients with baseline LVEF \<53% and GLS \<15%
8. Patients with pacemaker
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04790266
Study Brief:
Protocol Section:
NCT04790266