Status:
COMPLETED
Prevention of Cardiac Dysfunction During Breast Cancer Therapy
Lead Sponsor:
Torbjorn Omland
Collaborating Sponsors:
University Hospital, Akershus
Oslo University Hospital
Conditions:
Breast Cancer Female
Heart Failure
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Breast cancer is the most common cancer among women. The modern post-surgery treatment with chemotherapy, immunotherapy, radiation and hormone therapy has improved the overall 5-years survival drastic...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Women with histological evidence of invasive early breast cancer scheduled for adjuvant therapy with anti-cancer regimens that include anthracyclines
- Eastern Cooperative Oncology Group performance status 0-1
- Sinus rhythm
- Exclusion criteria:
- Age \<18 years
- Renal failure, i.e. serum creatinine greater than 133 mol/L (1.5mg/dL) or estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2
- Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L
- Systolic blood pressure \< 100 mgHg
- Uncontrolled hypertension
- Acute myocardial infarction within the last three months
- Contraindication to ACEI or ARB or sacubitril/valsartan, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- ACEI, ARB, aldosterone antagonist or sacubitril/valsartan use within 4 weeks of study start
- Clear indication for ACEI, ARB, aldosterone antagonist or sacubitril/valsartan therapy, including symptomatic heart failure
- History of hemodynamically significant valvular disease
- Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
- Participation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 halflives of enrollment, whichever is longer
- Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
- Contraindication or inability to undergo CMR examination
- Fertile women with inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. Fertile women are defined as following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- Life expectancy \< 12 months
Exclusion
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03760588
Start Date
January 31 2019
End Date
September 5 2024
Last Update
February 12 2025
Active Locations (4)
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1
Akershus University Hospital
Lørenskog, Norway, 1478
2
Stavanger University Hospital
Stavanger, Norway
3
University of North Norway
Tromsø, Norway
4
St Olavs Hospital
Trondheim, Norway