EUCTR2019-003518-15-RO
Active, not recruiting
Phase 1
A Follow-Up Study of Long-Term Efficacy of Patients with HER2-Positive Early Breast Cancer Who Had Been Enrolled in Study CT-P6 3.2
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ong-term safety and efficacy of treatment with CT-P6 (Herzuma) in HER-2 positive early breast cancer patients
- Sponsor
- Celltrion, Inc.
- Enrollment
- 216
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients will be included if they meet all of the following inclusion criteria:
- •1\. Patient completed the last CT\-P6 3\.2 follow\-up visit around October 2018 (regardless of her study treatement completion status).
- •2\. Patient is able to understand and to comply with protocol requirements, and instructions.
- •3\. Patient voluntarily agrees to participate in this study and has given a written informed consent prior to providing any information.
- •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 350
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range 0
Exclusion Criteria
- •Patients who meet the following exclusion citerion will be excluded from the study:
- •1\. Patient died during her participation in study CT\-P6 3\.2\.
Outcomes
Primary Outcomes
Not specified
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