Breast NeoplasmsNCT02771795
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
An observational study of Breast Neoplasms, run by Samsung Bioepis Co., Ltd. at 40 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Herceptin (trastuzumab) and SB3 (proposed trastuzumab biosimilar)
- Type of treatment
- Injection or infusion
- How many people
- 538 participants
- Where
- 40 sitesin 7 countries
- Study dates
- Apr 2016to Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.
Who may be able to join
- Subjects who received the study treatment of SB3-G31-BC.
- Subjects who provide informed consent.
Who cannot join
- Subjects unwilling to follow the study requirements are not eligible for the study.
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
Russia11 sites
SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department
Istra, Krasnogorsk District, 143423
S.I. Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, 115478
Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3
Moscow, 125284
SBI of Ryazan region "Regional Clinical Oncological Dispensary"
Ryazan, 390026
SBHI "Leningrad Regional Oncology Dispensary"
Saint Petersburg, 191014
Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
Saint Petersburg, 195271
Saint-Petersburg SBHI "City Clinical Oncology Dispensary"
Saint Petersburg, 197022
FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF
Saint Petersburg, 197758
SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)
Saint Petersburg, 197758
SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, 150054
BHI of Omsk Region "Clinical Oncology Dispensary"
Оmsk, 644013
Ukraine9 sites
Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council
Cherkasy, 18009
Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council
Dnipropetrovsk, 49102
Communal Non-commercial Enterprise Regional Center of Oncology
Kharkiv, 61070
Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
Kherson, 73000
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031
Regional Communal Institution Sumy Regional Clinical Oncological Dispensary
Sumy, 40005
Uzhgorod Central City Clinical Hospital City Oncological Center
Uzhhorod, 88000
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, 21029
Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council
Zaporizhzhya, 69040
Poland8 sites
Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku
Bialystok, 15 027
Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
Bydgoszcz, 85 796
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii
Gdansk, 80 952
Samodzielny Publiczny Zakład Opieki Zdrowotnej
Olsztyn, 10 228
Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego
Opole, 45-060
Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie
Poznan, 61 866
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
Warsaw, 02 781
Magodent Sp. Z o.o.
Warsaw, 03-984
Romania8 sites
Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
Baia Mare, 430031
SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala
Bucharest, 013811
Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica
Bucharest, 11171
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, 400015
Spitalul Clinic Judetean de Urgenta Cluj Napoca
Cluj-Napoca, 400349
Spitalul Municipal Ploiesti, Sectia Oncologie Medicala
Ploieşti, 100337
S.C Oncomed S.R.L
Timișoara, 300239
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300595
France2 sites
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030
Centre Hospitalier de Belfort-Montbeliard
Montbéliard, 25209
About this study
Official title: 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
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
- Breast Neoplasms
- Being tested
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Keywords
- HER2, Trastuzumab, Biosimilar, Cancer, Breast, Positive
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herceptin (trastuzumab)Drug
Also called Herceptin
Intravenous administration
SB3 (proposed trastuzumab biosimilar)Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Herceptin (trastuzumab) | Intravenous administration Receives: Drug: Herceptin (trastuzumab) | |
| SB3 (proposed trastuzumab biosimilar) | Intravenous administration Receives: Drug: SB3 (proposed trastuzumab biosimilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: approximately 56 months (median follow-up duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2020
- Study completionDec 2020
Why it stopped: Considering the life-threatening risk posed by COVID-19 disease to a fragile population, the Sponsor concluded that the benefit of continuing the study does not outweigh the risk to the safety of patients \& site staffs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771795
- Sponsor's protocol ID
- SB3-G31-BC-E
- Status last verified
- Jan 2024
- First submitted
- 9 May 2016
- Last updated
- 2 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pivot X, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko IM, Ahn JH, Im SA, Litwiniuk M, Shparyk YV, Ho GF, Kislov NV, Wojtukiewicz M, Sarosiek T, Chae YS, Ahn JS, Jang H, Kim S, Lee J, Yoon Y. Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e235822. doi: 10.1001/jamanetworkopen.2023.5822.
PubMed 37022687Pivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21.
PubMed 31445454
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02771795
- Acronym / sponsor ID
- SB3-G31-BC-E
- Conditions
- Breast Neoplasms
- Keywords
- HER2, Trastuzumab, Biosimilar, Cancer, Breast, Positive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Considering the life-threatening risk posed by COVID-19 disease to a fragile population, the Sponsor concluded that the benefit of continuing the study does not outweigh the risk to the safety of patients \& site staffs.
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 2 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herceptin (trastuzumab) | – | Drug: Herceptin (trastuzumab)Intravenous administration |
| SB3 (proposed trastuzumab biosimilar) | – | Drug: SB3 (proposed trastuzumab biosimilar)Intravenous administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.
Key inclusion criteria (2 listed)
- Subjects who received the study treatment of SB3-G31-BC.
- Subjects who provide informed consent.
Key exclusion criteria (1 listed)
- Subjects unwilling to follow the study requirements are not eligible for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herceptin (trastuzumab)Also: HerceptinIntravenous administration | Drug | Herceptin (trastuzumab) |
| SB3 (proposed trastuzumab biosimilar)Intravenous administration | Drug | SB3 (proposed trastuzumab biosimilar) |
Primary outcome
Number of Subjects With Asymptomatic Significant LVEF Decrease
Time frame: approximately 56 months (median follow-up duration)
Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF < 50%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37022687Pivot X, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko IM, Ahn JH, Im SA, Litwiniuk M, Shparyk YV, Ho GF, Kislov NV, Wojtukiewicz M, Sarosiek T, Chae YS, Ahn JS, Jang H, Kim S, Lee J, Yoon Y. Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e235822. doi: 10.1001/jamanetworkopen.2023.5822.
- Derived from this study: PubMed 31445454Pivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Samsung Bioepis Co., Ltd. at 40 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Russia, Ukraine, Poland, Romania, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Asymptomatic Significant LVEF Decrease (time frame: approximately 56 months (median follow-up duration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771795, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.