A Study of Cardiac Safety in Patients With HER2 Positive... | NCT01152606 | Trialant

A Study of Cardiac Safety in Patients With HER2 Positive... | NCT01152606 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trastuzumab [Herceptin]	Drug	There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death		On treatment and up to 5 years follow-up

Secondary Outcomes

Measure	Description	Time Frame
Time to onset and the time to recovery of symptomatic congestive heart failure		On treatment and up to 5 years follow-up
Incidence of asymptomatic cardiac failure and other significant cardiac conditions		On treatment and up to 5 years follow-up

Contacts/Locations Module

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins