Trials / Terminated
TerminatedNCT02771795
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 538 (actual)
- Sponsor
- Samsung Bioepis Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Herceptin (trastuzumab) | Intravenous administration |
| DRUG | SB3 (proposed trastuzumab biosimilar) | Intravenous administration |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2016-05-13
- Last updated
- 2024-02-02
- Results posted
- 2024-02-02
Locations
40 sites across 7 countries: Bulgaria, Czechia, France, Poland, Romania, Russia, Ukraine
Source: ClinicalTrials.gov record NCT02771795. Inclusion in this directory is not an endorsement.