An Observational Study of Kadcyla 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, non-interventional study (regulatory post-marketing surveillance) in approximately 3,000 patients who are to receive Kadcyla (trastuzumab emtansine). Patients with HER2-positive, unresectable locally advanced or metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane, and administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 6 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with HER2-positive, unresectable locally advanced or metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane

Exclusion Criteria:

- Hypersensitivity for Kadcyla or any ingredient in this product
Locations
Busan, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Ulsan, Korea, Republic of
Status: Recruiting
Start Date
May 2015
Completion Date
January 2020
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page