An Observational Study of Herceptin SC Safety in Breast Cancer

Roche

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02305628

ML29625

Details and patient eligibility

About

This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients administered Herceptin SC for the locally approved indications

Exclusion criteria

N/A

Trial design

600 participants in 1 patient group

Cohort

Description:

Method of continuous surveillance per standard of care