Trial Outcomes & Findings for A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC (NCT NCT02771795)
NCT ID: NCT02771795
Last Updated: 2024-02-02
Results Overview
Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%
Recruitment status
TERMINATED
Target enrollment
538 participants
Primary outcome timeframe
approximately 56 months (median follow-up duration)
Results posted on
2024-02-02
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
271
|
267
|
|
Overall Study
COMPLETED
|
56
|
45
|
|
Overall Study
NOT COMPLETED
|
215
|
222
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
47
|
37
|
|
Overall Study
Termination by premature discontinuation of study
|
168
|
185
|
Baseline Characteristics
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
Baseline characteristics by cohort
| Measure |
Herceptin (Trastuzumab)
n=271 Participants
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.
|
SB3 (Proposed Trastuzumab Biosimilar)
n=267 Participants
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.
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
266 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
528 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
271 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
538 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
270 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
536 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 56 months (median follow-up duration)Population: Long-term follow-up set
Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%
Outcome measures
| Measure |
Herceptin (Trastuzumab)
n=181 Participants
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.
|
SB3 (Proposed Trastuzumab Biosimilar)
n=186 Participants
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.
|
|---|---|---|
|
Number of Subjects With Asymptomatic Significant LVEF Decrease
|
2 Participants
|
1 Participants
|
Adverse Events
Herceptin (Trastuzumab)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 38 deaths
SB3 (Proposed Trastuzumab Biosimilar)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Herceptin (Trastuzumab)
n=271 participants at risk
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.
|
SB3 (Proposed Trastuzumab Biosimilar)
n=267 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
cardiac death
|
0.37%
1/271 • Through end of the study, approximately 4.7 years; Since SB3-G31-BC-E study was to assess the long-term cardiac safety for SB3 or Herceptin®, which was mainly about post-dose cardiac toxicities captured through cardiac assessments, non-serious AEs were not intended to be collected through this study.
For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.
|
0.00%
0/267 • Through end of the study, approximately 4.7 years; Since SB3-G31-BC-E study was to assess the long-term cardiac safety for SB3 or Herceptin®, which was mainly about post-dose cardiac toxicities captured through cardiac assessments, non-serious AEs were not intended to be collected through this study.
For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.
|
Other adverse events
Adverse event data not reported
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd.
Phone: +82-32-728-0371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee \- At least sixty (60) dayas prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow the Sponsor sixty (60) days to review and comment on them to ensure that the publication would not disclose any Confidential Information or impair the Sponsor's ability to obtain patent protection.
- Publication restrictions are in place
Restriction type: OTHER