Breast Neoplasms
Conditions
Keywords
HER2, Trastuzumab, Biosimilar, Cancer, Breast, Positive
Brief 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
Interventions
Intravenous administration
Intravenous administration
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who received the study treatment of SB3-G31-BC. * Subjects who provide informed consent.
Exclusion criteria
* Subjects unwilling to follow the study requirements are not eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Asymptomatic Significant LVEF Decrease | approximately 56 months (median follow-up duration) | Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50% |
Countries
Bulgaria, Czechia, France, Poland, Romania, Russia, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Herceptin (Trastuzumab) Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study. | 271 |
| SB3 (Proposed Trastuzumab Biosimilar) Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study. | 267 |
| Total | 538 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Termination by premature discontinuation of study | 168 | 185 |
| Overall Study | Withdrawal by Subject | 47 | 37 |
Baseline characteristics
| Characteristic | Herceptin (Trastuzumab) | SB3 (Proposed Trastuzumab Biosimilar) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 266 Participants | 262 Participants | 528 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 270 Participants | 266 Participants | 536 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 271 Participants | 267 Participants | 538 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 38 / 271 | 22 / 267 |
| other Total, other adverse events | 0 / 271 | 0 / 267 |
| serious Total, serious adverse events | 1 / 271 | 0 / 267 |
Outcome results
Primary
Number of Subjects With Asymptomatic Significant LVEF Decrease
Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%
Time frame: approximately 56 months (median follow-up duration)
Population: Long-term follow-up set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Herceptin (Trastuzumab) | Number of Subjects With Asymptomatic Significant LVEF Decrease | 2 Participants |
| SB3 (Proposed Trastuzumab Biosimilar) | Number of Subjects With Asymptomatic Significant LVEF Decrease | 1 Participants |