Prevention of heart failure during early breast cancer treatment

Phase 1

• Conditions: Prevention of cardiac dysfunction during adjuvant breast cancer treatment with anthracycline containing chemotherapy, with or without radiation or trastuzumab.; MedDRA version: 20.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.1Level: PTClassification code 10050528Term: Ejection fraction decreasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004909-41-NO
• Lead Sponsor: Akershus University Hospital Trust (HF)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-17
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 300

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Age <18 years
- Renal failure, i.e. serum creatinine greater than 133 umol/L (1,5 mg/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 mg Hg
- Uncontrolled hypertension
- Acute myocardial infarction within the last three months
- Contraindication to angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or sacubitril/valsartan, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- ACEI, ARB, or aldosterone antagonist use within 4 weeks of study start
- Clear indication for ACEI, ARB, or aldosterone antagonist 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 less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- Psychiatric or mental disorders, alcohol abuse or other substance abuse
- Language barriers or other factors which makes adherence to the study protocol difficult
- Suspected poor drug compliance
- Contraindication or inability to undergo CMR examination. Patients who are unable to complete the baseline CMR investigation will be excluded
- Pregnancy or breastfeeding
- Life expectancy < 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified