T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer

December 17, 2019 updated by: Yeon Hee Park, Samsung Medical Center

A Retrospective Study for Evaluation of Real-world Efficacy and Safety of T-DM1 in HER2-positive Locally-advanced Unresectable or Metastatic Breast Cancer

This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by Health Insurance Review & Assessment Service (HIRA). The medical records in approximately 1,000 patients of HER2-positive locally-advanced unresectable or metastatic breast cancer, who have received Kadcyla(Trastuzumab Emtansine, T-DM1) previously, will be collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

T-DM1 therapy has shown a survival benefit in previously trastuzumab-treated HER2-positive locally-advanced unresectable or metastatic breast cancer patients from clinical trials. However, the real-world efficacy and safety of T-DM1 in KOREA were not evaluated outside the controlled clinical trials. Therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of T-DM1 under the Korea National Health Insurance System. The medical records in approximately 1,000 patients with relapsed or De Novo metastatic breast cancer, who have received T-DM1 between Aug 03, 2017 and Dec 31, 2018 will be collected. Eligibility criteria included age ≥ 19 years, histologically confirmed HER2-positive, relapsed after primary surgery or initially metastatic breast cancer, and previous trastuzumab treated. Efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, duration of response and time to next treatment. Safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with T-DM1 therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
        • Korea University Ansan Hospital
      • Anyang, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Bucheon, Korea, Republic of, 14647
        • The Catholic University of Korea, Bucheon St. Mary's Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Busan, Korea, Republic of, 49201
        • Dong-A University Hospital
      • Busan, Korea, Republic of, 47392
        • Inje University Busan Paik Hospital
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of, 46033
        • Dongnam Institute of Radiological&Medical Sciences
      • Changwon, Korea, Republic of, 51472
        • Gyeongsang National University Changwon Hospital
      • Cheonan, Korea, Republic of, 31116
        • Dankook University Hospital
      • Cheonan, Korea, Republic of, 31151
        • Soonchunhyang University Cheonan Hospital
      • Cheonju, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center
      • Daegu, Korea, Republic of, 42601
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of, 41199
        • Daegu Fatima Hospital.
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Daejeon, Korea, Republic of, 35365
        • Konyang University Hospital
      • Daejeon, Korea, Republic of, 34943
        • The Catholic University of Korea Daejeon St. Mary's Hospital
      • Daejeon, Korea, Republic of, 35233
        • Daejeon Eulji Medical Center, Eulji University.
      • Gangneung, Korea, Republic of, 25440
        • Gangneung Asan Hospital
      • Goyang, Korea, Republic of, 10408
        • National Cancer Center
      • Gwangju, Korea, Republic of, 61453
        • Chosun University Hospital
      • Gyeongju, Korea, Republic of, 38067
        • Dongguk University Gyeongju Hospital.
      • Hwaseong-si, Korea, Republic of, 18450
        • Hallym University Dongtan Sacred Heart Hospital
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Ilsan, Korea, Republic of, 10326
        • Dongguk University Ilsan Hospital
      • Ilsan, Korea, Republic of, 10380
        • nje University Ilsan Paik Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of, 21431
        • The Catholic University of Korea Incheon St. Mary's Hospital
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Jinju, Korea, Republic of, 52727
        • Gyeongsang National University Hospital
      • Seongnam, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seongnam, Korea, Republic of, 13496
        • CHA University Bundang Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 07345
        • The Catholic University of Korea Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Seoul Hospital
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 02447
        • Kangdong Kyung Hee University Medical Center
      • Suwon, Korea, Republic of, 16499
        • Ajou University Hospital
      • Suwon, Korea, Republic of, 16247
        • The Catholic University of Korea St. Mary's Hospital
      • Uijeongbu, Korea, Republic of, 11765
        • The Catholic University of Korea Uijeongbu St. Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hospital
      • Yangsan, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with locally-advanced unresectable or metastatic HER2-positive breast cancer, who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System

Description

Inclusion Criteria:

  1. Age ≥19 years at the time of study registration
  2. Participants must have histologically confirmed HER2-positive breast cancer
  3. Locally advanced unresectable or metastatic patients
  4. Patients who have received T-DM1 therapy between Aug 2017 and December 2018 under the Korea National Health Insurance System

Exclusion Criteria:

• Patients who have received T-DM1 therapy outside of the Korea National Health Insurance System

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free Survival, PFS
Time Frame: Until September 30, 2019
Time from the start of T-DM1 to disease progression or death from any cause
Until September 30, 2019
Incidence of adverse events
Time Frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events
Until September 30, 2019

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Next Treatment, TTNT
Time Frame: Until September 30, 2019
Time from the end of T-DM1 to institution of next systemic therapy
Until September 30, 2019
Objective Response Rate, ORR
Time Frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response
Until September 30, 2019
Overall Survival, OS
Time Frame: Until September 30, 2019
Time from the start of T-DM1 to death from any cause
Until September 30, 2019
Disease Control Rate, DCR
Time Frame: Until September 30, 2019
The proportion of subjects confirmed complete or partial response or stable disease
Until September 30, 2019
Duration of response
Time Frame: Until September 30, 2019
Time from documentation of tumor response to disease progression
Until September 30, 2019
Adverse events of special interest
Time Frame: Until September 30, 2019
Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1
Until September 30, 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Korean Cancer Study Group
Health Insurance Review & Assessment Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KCSG BR19-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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