An Observational Study of Herceptin SC Safety in Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- All patients administered Herceptin SC for the locally approved indications

- All patients must provide informed consent

Exclusion Criteria:

N/A
Locations
Busan, Korea, Republic of
Status: Not yet recruiting
Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Gyeonggi-do, Korea, Republic of
Status: Not yet recruiting
Gyeongsangnam-do, Korea, Republic of
Status: Not yet recruiting
Gyeongsangnam-do, Korea, Republic of
Status: Not yet recruiting
Jeollanam-do, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Not yet recruiting
Seoul, Korea, Republic of
Status: Not yet recruiting
Ulsan, Korea, Republic of
Status: Recruiting
Start Date
May 2015
Completion Date
May 2020
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page