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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005663-17-CZ

Enrollment

573

Registered

2016-04-11

Start date

2016-04-11

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Concentrati

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;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. ;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% ;Timepoint(s) of evaluation of this end point: All analysis will be performed periodically and at the end of the study	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Bulgaria, Czech Republic, France, Poland

Contacts

Public ContactQuintiles Contact Centre

Quintiles Limited

0018622613634

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026