An Observational Study of Kadcyla Safety in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Post-Marketing Surveillance of Kadcyla in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305641
• Other study ID #: ML29629
• Status: Completed
• Start date: May 21, 2015
• Est. completion date: August 10, 2021

Study information

• Verified date: January 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	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	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Bucheon St Mary's hospital	Gyeonggi-do
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Gyeonggi-do
Korea, Republic of	St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Uijeongbu St. Mary's Hospital	Gyeonggi-do
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Catholic Kwandong University International St. Mary'S Hospital.	Incheon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Chonbuk National Uni Hospital	Jeollabuk-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Presbyterian Medical Center	Jeonju-si
Korea, Republic of	Wonkwang University School of Medicine & Hospital	Jeonlabuk-do
Korea, Republic of	NHIC Ilsan Hospital	Kyonggi-do
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	Gangdong Kyung Hee University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences	Seoul
Korea, Republic of	Korea University Anam Hospital	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	Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon City
Korea, Republic of	Ulsan University Hosiptal	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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