Observational Study of Perjeta Safety in Breast Cancer
Conditions
Metastatic Breast Cancer, Neoadjuvant Treatment of 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 Perjeta (pertuzumab) therapy to treat metastatic or locally unresectable recurrent breast cancer. Patients are to never have received chemotherapy or anti-HER2 therapy for their metastatic disease with HER2 positivity in Korea. Patients will be asked to provide informed consent and registered by the doctor in charge of surveillance and treated with Perjeta under the approval conditions of the product in Korea.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity

- Written informed consent

Exclusion Criteria:

- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients

- Contraindications to Perjeta according to SmPC

- Pregnancy and lactation
Locations
Busan, 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: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Start Date
February 2015
Completion Date
May 2019
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page