A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 positive Breast Cancer Who Have Completed the SB3-G31-BC study.
- Registration Number
- CTRI/2020/02/023210
- Lead Sponsor
- Samsung Bioepis Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
[Survival Only Cohort]
Subjects must meet all of the following criteria to be eligible for the study:
1. Subjects who received SB3 or Herceptin® according to the clinical trial SB3-G31-BC.
2. Subjects who provide informed consent. If prospective data collection is not possible (e.g. when the subject is deceased or lost to follow-up), a waiver of informed consent/authorization will be requested for the retrospective data collection from medical records, where applicable and in accordance with national regulations and local ethics. If ICF waiver for the deceased subject is not allowed, their next-of-kin (if applicable) will be informed accordingly and will be asked to give their consent where applicable and approved by IRB/IEC and in accordance with national regulations.
There are no exclusion criteria for the Survival Only Cohort.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method