Long-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study

• Register: EUCTR
• Last refreshed on: 5 January 2021
• Main ID: EUCTR2015-005663-17-CZ
• Date of registration: 11/04/2016
• Prospective Registration: Yes
• Primary sponsor: Samsung Bioepis Co., Ltd.
• Public title: Long-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study
• Scientific 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
• Date of first enrolment: 11/04/2016
• Target sample size: 573
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005663-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Follow up study - NO IMP will be administered If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, France, Poland

Contacts

• Name: Quintiles Contact Centre
• Affiliation: Quintiles Limited

• Name: Quintiles Contact Centre
• Affiliation: Quintiles Limited

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following criteria to be eligible for the study:
1.Subjects who have completed the study treatment of SB3-G31-BC according to the protocol.
2.Subjects must provide informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 516
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57

Exclusion criteria:
Subjects unwilling to follow the study requirements are not eligible for the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Subjects with primary HER2 positive early or locally advanced breast cancer, who have completed the study treatment of SB3-G31-BC.
MedDRA version: 18.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: SB3 ( Trastuzumab biosimilar)
Product Code: SB3
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: HERCEPTIN®
Product Name: Herceptin®
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: All analysis will be performed periodically and at the end of the study

Main Objective: The primary objective is to observe the incidence of symptomatic congestive heart failure (CHF) NYHA class II,III and IV and asymptomatic LVEF decrease in patients who participated in the SB3-G31-BC Study and treated with SB3 ( proposed trastuzumab biosimilar) or Herceptin® as neoadjuvant and adjuvant treatment.

Secondary Objective: The secondary objectives are:
To observe the incidence of cardiac death and other significant cardiac conditions
To observe the long term efficacy of SB3 compared to Herceptin® by
-event-free survival
-overall survival

Primary end point(s): The incidence of symptomatic congestive heart failure (CHF) and asymptomatic significant LVEF decrease
-CHF, defined as NYHA II, III, IV, confirmed by a cardiologist, accompanied by a significant LVEF decrease.
-Significant LVEF decrease, defined as an absolute decline of at least 10 % points from baseline LVEF (LVEF at screening of SB3-G31-BC) and resulting LVEF less than 50%

Secondary Outcome(s)

Secondary end point(s): 1. The incidence of cardiac death and other significant cardiac conditions
-Cardiac death, defined as death definitely as a result of heart failure, myocardial infarction, or documented arrhythmia or as probable cardiac death within 24 hours of a cardiac event.
2. Event-free survival (EFS), defined as the time from the date of randomisation for SB3-G31- BC to the date where an event occurs. An event is disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.
3. Overall survival (OS), defined as the time from the date of randomisation for SB3-G31-BC to the date of death, regardless of the cause of death. Subjects who were alive at the time of analysis will be censored at the date of the last follow up assessment.

Timepoint(s) of evaluation of this end point: All analysis will be performed periodically and at the end of the study

Secondary ID(s)

SB3-G31-BC-E

Source(s) of Monetary Support

Samsung Bioepis Co.,Ltd.

Ethics review

Status: Approved
Approval date: 16/03/2016
Contact: