Status:
COMPLETED
Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
Lead Sponsor:
Oncology Institute of Southern Switzerland
Collaborating Sponsors:
Cardiocentro Ticino
North Estonia Medical Centre
Conditions:
Cardiotoxicity
Eligibility:
FEMALE
18+ years
Brief Summary
To assess the role of myocardial oedema on CMR (T2 mapping) after radiation therapy and cardiotoxic systemic therapy in predicting the incidence of cardiotoxicity, defined as by consensus guidelines\*...
Detailed Description
Overall study schedule The Overall Study Schedule is summarized in the assessment schedule (appendix 1). This study is composed of three subsequent phases: a Run-In Phase, a RT/Systemic Therapy Phase...
Eligibility Criteria
Inclusion
- Written informed consent must be obtained before any assessment is performed
- Age ≥ 18 years at visit 1
- Performance status ECOG 0-1
- \*Stage I-III histology proven breast cancer
- Treated with adjuvant radiotherapy and neo/adjuvant anthracycline and/or trastuzumab-based therapy +/- hormonal therapy
- 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
- Known metastatic spread of any cancer
- Known active or recurrent hepatic disorder (cirrhosis, hepatitis), ASAT/ALAT 2xULN
- Renal function decrease (eGFR \< 30 ml/min)
- Known coronary artery disease
- Angina pectoris
- Positive or missing pregnancy test (pre- and perimenopausal women) at enrolment visit
- Patients with baseline LVEF \<53% and GLS \<15%
- Patients with pacemaker
Key Trial Info
Start Date :
September 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04790266
Start Date
September 15 2020
End Date
December 14 2023
Last Update
November 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oncology Institute of Italian Switzerland
Bellinzona, Canton Ticino, Switzerland, 6500