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

Phase 1

• Conditions: ong-term safety and efficacy of treatment with CT-P6 (Herzuma) in HER-2 positive early breast cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003518-15-RO
• Lead Sponsor: Celltrion, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-21
• Study Start: 2022-04-12
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 216

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified