Who is sponsoring NCT00459771?

NCT00459771 is sponsored by The Netherlands Cancer Institute.

What condition does NCT00459771 study?

NCT00459771 studies Breast Cancer.

What drugs are being tested in NCT00459771?

Interventions: AT1 blocker candesartan, Placebo.

What is the status of NCT00459771?

NCT00459771 is currently COMPLETED.

Last reviewed 2014-12-01 · How we verify

Prospective, Randomized, Pharmacological Intervention Study; Evaluating Effect of the Angiotensin II-receptor (AT1) Blocker Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity in Patients Treated With Trastuzumab

NCT00459771 Phase 3 COMPLETED

Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab.

Details

Lead sponsor	The Netherlands Cancer Institute
Phase	Phase 3
Status	COMPLETED
Enrolment	210
Start date	2007-06
Completion	2014-12

Conditions

Breast Cancer

Interventions

AT1 blocker candesartan
Placebo

Primary outcomes

The occurrence of cardiotoxicity, defined as a decline in LVEF (MUGA) of more than 15% or a decrease of less than 15% to an absolute value below 45%. — during 1 year trastuzumab therapy and during 26 weeks after discontinuation of trastuzumab

Countries

Netherlands