scholarly journals Faculty Opinions recommendation of Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 × 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol.

2019 ◽  
Author(s):  
Maurie Markman
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Cancer Therapy ◽  
Cardiac Dysfunction ◽  
Breast Cancer Therapy ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Adjuvant Breast Cancer

scholarly journals Rationale and design of the PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy (PRADA II) trial: a randomized, placebo-controlled, multicenter trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
A Mecinaj ◽  
G Gulati ◽  
SL Heck ◽  
E Holte ◽  
MW Fagerland ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Ejection Fraction ◽  
Early Breast Cancer ◽  
Cardiac Dysfunction ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Controlled Study ◽  
Breast Cancer Therapy ◽  
Adjuvant Breast Cancer

Abstract Background Recent advances in the treatment algorithms of early breast cancer have markedly improved overall survival. However, anthracycline- and trastuzumab-associated cardiotoxicity may lead to dose-reduction or halt in potentially life-saving adjuvant cancer therapy. Early initiated neurohormonal blockade may prevent or attenuate the cardiotoxicity-induced reduction in cardiac function, but prior studies have been inconclusive. The angiotensin receptor-neprilysin inhibitor sacubitril/valsartan has been shown to be superior to traditional treatment in heart failure with reduced ejection fraction, but its cardioprotective effects in the cardio-oncology setting remains to be tested. Objective To assess if sacubitril/valsartan given concomitantly with early breast cancer treatment regimens including anthracyclines, with or without trastuzumab, may prevent cardiac dysfunction. Methods PRADA II is a randomized, placebo-controlled, double blind, multi-center, investigator-initiated clinical trial. Breast cancer patients from four university hospitals in Norway, scheduled to receive (neo-)adjuvant chemotherapy with epirubicin independently of additional trastuzumab/pertuzumab treatment, will be randomized 1:1 to sacubitril/valsartan or placebo. The target dose is 97/103 mg b.i.d. The patients will be examined with cardiovascular magnetic resonance (CMR), echocardiography, circulating cardiovascular biomarkers and functional testing at baseline, at end of anthracycline treatment and following 18 months after enrolment. The primary outcome measure of the PRADA II trial is the change in left ventricular ejection fraction (LVEF) by CMR from baseline to 18 months. Secondary outcomes include change in LV function by global longitudinal strain by CMR and echocardiography and change in circulating cardiac troponin concentrations. Results The study is ongoing. Results will be published when the study is completed. Conclusion PRADA II is the first randomized, placebo-controlled study of sacubitril/valsartan in a cardioprotective setting during (neo-)adjuvant breast cancer therapy. It may provide new insight in prevention of cardiotoxicity in patients receiving adjuvant or neo-adjuvant therapy containing anthracyclines. Furthermore, it may enable identification of patients at higher risk of developing cardiotoxicity and identification of those most likely to respond to cardioprotective therapy. Trial registration The trial is registered in the ClinicalTrials.gov registry (identifier NCT03760588). Registered 30 November 2018.

scholarly journals Rationale and Design of the Prevention of Cardiac Dysfunction during an Adjuvant Breast Cancer Therapy (PRADA) Trial

Cardiology ◽  
2012 ◽  
Vol 123 (4) ◽  
pp. 240-247 ◽  
Author(s):  
Siri Lagethon Heck ◽  
Geeta Gulati ◽  
Anne Hansen Ree ◽  
Jeanette Schulz-Menger ◽  
Berit Gravdehaug ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Cardiac Dysfunction ◽  
Breast Cancer Therapy ◽  
Adjuvant Breast Cancer

Abstract CT321: Prevention of cardiac dysfunction during adjuvant breast cancer therapy: the PRADA study

2014 ◽  
Author(s):  
Geeta Gulati ◽  
Siri Lagethon Heck ◽  
Anne Hansen Ree ◽  
Åse Bratland ◽  
Kjetil Steine ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Therapy ◽  
Cardiac Dysfunction ◽  
Breast Cancer Therapy ◽  
Adjuvant Breast Cancer
Sign in / Sign up

Export Citation Format

Share Document