An Observational Study of Kadcyla Safety in Breast Cancer
Post-Marketing Surveillance of Kadcyla in Breast Cancer
1 other identifier
observational
563
1 country
38
Brief Summary
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedStudy Start
First participant enrolled
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedJanuary 11, 2023
January 1, 2023
6.2 years
November 28, 2014
January 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
Up to 8 years
Secondary Outcomes (1)
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Up to 8 years
Study Arms (1)
Cohort
Method of continuous surveillance per standard of care
Eligibility Criteria
Korean patients administered Kadcyla infusion at physician's discretion
You may qualify if:
- Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.
You may not qualify if:
- Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
- A pediatric patient (age ≤18 years)
- Hypersensitivity for Kadcyla or any ingredient in this product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kosin University Gospel Hospital
Busan, 49267, South Korea
Pusan National University Hospital
Busan, 602-739, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion
Daegu, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Uijeongbu St. Mary's Hospital
Gyeonggi-do, 11765, South Korea
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068, South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, 14584, South Korea
Bucheon St Mary's hospital
Gyeonggi-do, 14647, South Korea
St. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Inha University Hospital
Incheon, 22332, South Korea
Catholic Kwandong University International St. Mary'S Hospital.
Incheon, South Korea
Chonbuk National Uni Hospital
Jeollabuk-do, 561-712, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Presbyterian Medical Center
Jeonju, 54987, South Korea
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538, South Korea
NHIC Ilsan Hospital
Kyonggi-do, 411-719, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 003-722, South Korea
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Gangdong Kyung Hee University Hospital
Seoul, 05278, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
ChungAng University Hospital
Seoul, 06973, South Korea
Yeouido St. Mary's Hospital
Seoul, 07345, South Korea
Ewha Womans University Mokdong Hospital
Seoul, 07985, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
SMG-SNU Boramae Medical Center
Seoul, 156-707, South Korea
Ajou University Hospital
Suwon, 443-721, South Korea
Ulsan University Hosiptal
Ulsan, 44033, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2014
First Posted
December 2, 2014
Study Start
May 21, 2015
Primary Completion
August 10, 2021
Study Completion
August 10, 2021
Last Updated
January 11, 2023
Record last verified: 2023-01