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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04202328
• Other study ID #: KCSG BR19-15
• Status: Not yet recruiting
• Start date: December 19, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: Park Yeon Hee
• Phone: +82-2-3410-1780
• Email: yhparkhmo[@]skku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	The Catholic University of Korea, Bucheon ST. Mary's Hospital	Bucheon
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Dongnam Institute of Radiological&Medical Sciences	Busan
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Dankook University Hospital	Cheonan
Korea, Republic of	Soonchunhyang University Cheonan Hospital	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Cheonju
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Daegu Fatima Hospital.	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Daejeon Eulji Medical Center, Eulji University.	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Dongguk University Gyeongju Hospital.	Gyeongju
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Dongguk University Ilsan Hospital	Ilsan
Korea, Republic of	nje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	The Catholic University of Korea Incheon ST. Mary's Hospital	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Cha University Bundang Medical Center	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	ChungAng University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kangdong Kyung Hee University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Soonchunhyang University Seoul Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Yeouido ST. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	The Catholic University of Korea ST. Mary's Hospital	Suwon
Korea, Republic of	The Catholic University of Korea Uijeongbu ST. Mary's Hospital	Uijeongbu
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	Health Insurance Review & Assessment Service, Korean Cancer Study Group

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free Survival, PFS	Time from the start of T-DM1 to disease progression or death from any cause	Until September 30, 2019
Primary	Incidence of adverse events	Number (percentage) of subjects reporting adverse events	Until September 30, 2019
Secondary	Time to Next Treatment, TTNT	Time from the end of T-DM1 to institution of next systemic therapy	Until September 30, 2019
Secondary	Objective Response Rate, ORR	The proportion of subjects confirmed complete or partial response	Until September 30, 2019
Secondary	Overall Survival, OS	Time from the start of T-DM1 to death from any cause	Until September 30, 2019
Secondary	Disease Control Rate, DCR	The proportion of subjects confirmed complete or partial response or stable disease	Until September 30, 2019
Secondary	Duration of response	Time from documentation of tumor response to disease progression	Until September 30, 2019
Secondary	Adverse events of special interest	Number (percentage) of subjects reporting adverse events of special interest associated with T-DM1	Until September 30, 2019