NCT05465031 - Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM) | Biotech Hunter

Enrollment

600

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

February 28, 2029

Conditions

Breast CancerNeoplasm, BreastBreast DiseasesAntihypertensive AgentsSacubitril/ValsartanAngiotensin II Type 1 Receptor BlockersAngiotensin Receptor AntagonistsMolecular Mechanisms of Pharmacological ActionHeart FailureCardiac ToxicityCancer, Therapy-RelatedCancer Therapy-Related Cardiac DysfunctionCardiotoxicity

Interventions

DRUG

Sacubitril-valsartan

Sacubitril/valsartan (Entresto®) administered in the target dose of 200 mg b.i.d. (97/103 mg of sacubitril and valsartan respectively) for the period of 24 months. In case of target dose intolerance, the physician-in-charge will be able to reduce the dose to 100 mg b.i.d. (49/51mg of sacubitril and valsartan respectively). Physicians will be strongly encouraged to evaluate the possibility of drug dose uptitration to the target dose of 200 mg b.i.d.

DRUG

Placebo

Placebo matching the sacubitril/valsartan (Entresto®) administered in the target dose matching the dosing of 200 mg b.i.d. (97/103 mg) for the period of 24 months. In case of intolerance of target dose of placebo, the physician-in-charge will be able to reduce the dose to placebo matching the dose of 100 mg b.i.d. (49/51mg). Physicians will be strongly encouraged to evaluate the possibility of drug dose uptitration to the target dose of placebo matching the dose of 200 mg b.i.d.

Trial Locations (4)

41800

ACTIVE_NOT_RECRUITING

Silesian Center for Heart Diseases, Zabrze

44102

RECRUITING

Maria Sklodowska-Curie Institute - Oncology Centre (MSCI), Gliwice Branch, Gliwice

45-061

RECRUITING

Regional Cancer Centre in Opole, Opole

25-734

RECRUITING

Holy Cross Cancer Centre, Cardio-Oncology Division, Kielce