ong-term Follow-up Study for Cardiac Safety in the Patients with Breast Cancer Who Have Completed the Main Study
Phase 1
- Conditions
- Subjects with primary HER2 positive early or locally advanced breast cancer, who have completed the study treatment of SB3-G31-BC.Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 19.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2015-005663-17-FR
- Lead Sponsor
- Samsung Bioepis Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 573
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method