Clinical Trial Results:
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
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Summary
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EudraCT number |
2019-003518-15 |
Trial protocol |
PL RO |
Global end of trial date |
21 Oct 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jun 2022
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First version publication date |
11 Jun 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CT-P6 4.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Celltrion, Inc.
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Sponsor organisation address |
23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014
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Public contact |
Celltrion, Inc., Celltrion, Inc., +82 8505000, contact@celltrion.com
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Scientific contact |
Celltrion, Inc., Celltrion, Inc., +82 8505000, contact@celltrion.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Mar 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Oct 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Oct 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To collect long-term efficacy data from patients who completed the last follow-up visit in main study.
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Protection of trial subjects |
The study was conducted according to the principles of the International Council for Harmonisation (ICH) harmonised tripartite guideline E6(R1): Good Clinical Practice (GCP) (ICH 1996) and the ethical principles that have their origin in the World Medical Association Declaration of Helsinki.
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Background therapy |
This is a 6-year post-treatment follow-up study extended from the main study, CT-P6 3.2 (EudraCT Number: 2013-004525-84). Therefore, study drug has not been administered in this extended follow-up study. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Jan 2020
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
6 Years | ||
Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belarus: 42
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Country: Number of subjects enrolled |
Georgia: 30
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Country: Number of subjects enrolled |
Poland: 12
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Country: Number of subjects enrolled |
Romania: 18
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Country: Number of subjects enrolled |
Russian Federation: 76
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Country: Number of subjects enrolled |
Ukraine: 38
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Worldwide total number of subjects |
216
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
193
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
The investigator/center personnel from each center contacted all their respective patients who were known to be alive at the last follow-up visit of the main study via telephone to inform them of the observational extended follow-up study and to invite them to an on-center enrollment visit. | |||||||||
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Pre-assignment
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Screening details |
Female patients age 18 years or older with a pathologically confirmed, newly diagnosed, operable early breast cancer (Stage I, II, or IIIa) who completed the last FU visit of main study around October 2018 (regardless of her study treatment completion status) were included. Patients who died during participation in main study were not eligeble. | |||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
This was open-label study.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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CT-P6 | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Trastuzumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
8 mg/kg body weight on Day 1 of Neoadjuvant Period Cycle 1, followed by 6 mg/kg body weight repeated every 3 weeks for 8 cycles
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Arm title
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Herceptin | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Trastuzumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
8 mg/kg body weight on Day 1 of Neoadjuvant Period Cycle 1, followed by 6 mg/kg body weight repeated every 3 weeks for 8 cycles
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Baseline characteristics reporting groups
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Reporting group title |
CT-P6
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Herceptin
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Intent-to-Treat Set
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients in the ITT set for whom data were collected for the extension study.
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End points reporting groups
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Reporting group title |
CT-P6
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Reporting group description |
- | ||
Reporting group title |
Herceptin
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Reporting group description |
- | ||
Subject analysis set title |
Intent-to-Treat Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All patients in the ITT set for whom data were collected for the extension study.
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End point title |
Overall Survival | |||||||||||||||
End point description |
The interval between the date of randomization in the main study and the date of death from any cause.
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End point type |
Primary
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End point timeframe |
Up to approximately 6 years.
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Statistical analysis title |
Overall Survival | |||||||||||||||
Statistical analysis description |
All patients in the ITT set for whom data were collected for the extension study.
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Comparison groups |
CT-P6 v Herceptin
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Number of subjects included in analysis |
216
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||||||||
Method |
Adjusted stratified Cox Regression model | |||||||||||||||
Parameter type |
Hazard ratio (HR) | |||||||||||||||
Point estimate |
0.59
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.17 | |||||||||||||||
upper limit |
2.02 | |||||||||||||||
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End point title |
Disease-Free Survival | |||||||||||||||
End point description |
The interval between the date of breast surgery to disease progression, recurrence or death from any cause, whichever occurs first. Patients who underwent breast surgery are included in the disease-free survival analysis.
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End point type |
Primary
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End point timeframe |
Up to approximately 6 years.
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Statistical analysis title |
Disease-Free Survival | |||||||||||||||
Statistical analysis description |
All patients in the ITT set for whom data were collected for the extension study.
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Comparison groups |
Herceptin v CT-P6
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Number of subjects included in analysis |
216
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||||||||
Method |
Adjusted stratified Cox Regression model | |||||||||||||||
Parameter type |
Hazard ratio (HR) | |||||||||||||||
Point estimate |
1.07
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.5 | |||||||||||||||
upper limit |
2.32 | |||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Up to approximately 6 years.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
18.1
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The study does not have a specific safety objective, nor protocol-mandated products were administered. It was planned to use existing data collected/medical records as data sources, hence, there was no requirement for AE to be recorded in the eCRF or equivalent. PI was advised to report any SAE/AE believed to be related to any medicinal product, according to the standard spontaneous reporting procedures for marketed products in their country. No specific AE were reported during the study. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
