Clinical trial NCT02771795: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Neoplasms
Keywords: HER2
Trastuzumab
Biosimilar
Cancer
Breast
Positive
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 538
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with HER2 positive early or locally advanced breast cancer who received SB3 or Herceptin according to clinical trial SB3-G31-BC.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Asymptomatic Significant LVEF Decrease
timeFrame: approximately 56 months (median follow-up duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Vratsa
country: Bulgaria
facility: Complex Oncological Center - Vratsa, EOOD
city: Praha
country: Czechia
facility: ONKOCENTRUM Medicon Services s.r.o.
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Montbéliard
country: France
facility: Centre Hospitalier de Belfort-Montbeliard
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej
city: Opole
country: Poland
facility: Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego
city: Poznań
country: Poland
facility: Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie
city: Warszawa
country: Poland
facility: Magodent Sp. Z o.o.
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare
city: Bucuresti
country: Romania
facility: SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala
city: Bucuresti
country: Romania
facility: Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti, Sectia Oncologie Medicala
city: Timisoara
country: Romania
facility: S.C Oncomed S.R.L
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara
city: Istra
country: Russian Federation
facility: SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department
state: Krasnogorsk District
city: Moscow
country: Russian Federation
facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3
city: Ryazan
country: Russian Federation
facility: SBI of Ryazan region "Regional Clinical Oncological Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg SBHI "City Clinical Oncology Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: SBHI "Leningrad Regional Oncology Dispensary"
city: Saint-Petersburg
country: Russian Federation
facility: FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF
city: Saint-Petersburg
country: Russian Federation
facility: SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)
city: Yaroslavl
country: Russian Federation
facility: SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"
city: Оmsk
country: Russian Federation
facility: BHI of Omsk Region "Clinical Oncology Dispensary"
city: Cherkasy
country: Ukraine
facility: Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council
city: Dnipropetrovsk
country: Ukraine
facility: Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council
city: Kharkiv
country: Ukraine
facility: Communal Non-commercial Enterprise Regional Center of Oncology
city: Kherson
country: Ukraine
facility: Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Sumy
country: Ukraine
facility: Regional Communal Institution Sumy Regional Clinical Oncological Dispensary
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Central City Clinical Hospital City Oncological Center
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Oncological Dispensary
city: Zaporizhzhia
country: Ukraine
facility: Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council
Study officials:
References:
citation: Pivot 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.