A Follow-Up Study of Long-Term Efficacy of Patients with HER2-Positive Early Breast Cancer Who Had Been Enrolled in Study CT-P6 4.2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003518-15-PL

Enrollment

350

Registered

2019-12-03

Start date

2020-03-10

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

Long-term safety and efficacy of treatment with CT-P6 (Herzuma) in HER-2 positive early breast cancer patients

Interventions

Trade Name: Herzuma Product Name: Herzuma Pharmaceutical Form: Solution for injection INN or Proposed INN: TRASTUZUMAB CAS Number: 180288-69-1 Current Sponsor code: CT-P6 Other descriptive name: Herzu

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this extended follow-up study is to collect long-term efficacy data (overall survival, disease-free survical, progression-free survival and follow-up duration) from patients who completed the last follow-up visit in Study CT-P6 3.2.;Secondary Objective: Not applicable;Primary end point(s): OS, defined as the interval between the date the date of randomization in the main study and the date of death from any cause. DFS, defined as the interval between the date of breast surgery in the main study and the date of disease progression, recurrence, or death, whicever occurs first, from any cause. PFS, defined as the interval between the date of randomization in the main study and the date of disease progression, recurrence, or death, whicever occurs first, from any cause. Follow-up duration, the interval between the date of randomization in the main study and the date of the last available information. An algorithm to determine the date of the last available information will be described in the Statistical Analysis Plan (SAP).;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: The objective of this extended follow-up study is to collect long-term efficacy data (overall survival, disease-free survical, progression-free survival and follow-up duration) from patients who completed the last follow-up visit in Study CT-P6 3.2.;Secondary Objective: Not applicable;Primary end point(s): OS, defined as the interval between the date the date of randomization in the main study and the date of death from any cause. DFS, defined as the interval between the date of breast surgery in the main study and the date of disease progression, recurrence, or death, whicever occurs first, from any cause. PFS, defined as the interval between the date of randomization in the main study and the date of disease progression, recurrence, or death, whicever occurs first, from any cause. Follow-up duration, the interval between the date of randomization in the main study and the date of the last available information. An algorithm to determine the date of the last available information will be described in the Statistical Analysis Plan (SAP).;Timepoint(s) of evaluation of this end point: Not applicable

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Secondary

Measure	Time frame
Secondary end point(s): No secondary endpoints;Timepoint(s) of evaluation of this end point: No secondary timepoints	—

Countries

Belarus, Georgia, Poland, Romania, Russian Federation, Ukraine

Contacts

Public ContactSungYun Kim

Celltrion, Inc.

SungHyun.Kim@celltrion.com+82328505778

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026