An Observational Study of Kadcyla Safety in Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT02305641
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 563
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (38)
Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion
🇰🇷Daegu, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
St. Vincent's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Jeollanam-do, Korea, Republic of
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
🇰🇷Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju-si, Korea, Republic of
NHIC Ilsan Hospital
🇰🇷Kyonggi-do, Korea, Republic of
Chonbuk National Uni Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon City, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Gangdong Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
ChungAng University Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Bucheon St Mary's hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Gyeongsangnam-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Catholic Kwandong University International St. Mary'S Hospital.
🇰🇷Incheon, Korea, Republic of
Wonkwang University School of Medicine & Hospital
🇰🇷Jeonlabuk-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Ulsan University Hosiptal
🇰🇷Ulsan, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of