An Observational Study of Kadcyla Safety in Breast Cancer

January 10, 2023 updated by: Hoffmann-La Roche

Post-Marketing Surveillance of Kadcyla in Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

563

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • 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
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Daegu, Korea, Republic of
        • Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion
      • Daejeon, Korea, Republic of, 35015
        • Chungnam national university hospital
      • Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Korea, Republic of, 11765
        • Uijeongbu St. Mary's Hospital
      • Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
      • Gyeonggi-do, Korea, Republic of, 14584
        • Soonchunhyang University Bucheon Hospital
      • Gyeonggi-do, Korea, Republic of, 14647
        • Bucheon St Mary's Hospital
      • Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Catholic Kwandong University International St. Mary'S Hospital.
      • Jeollabuk-do, Korea, Republic of, 561-712
        • Chonbuk National Uni Hospital
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Jeonju-si, Korea, Republic of, 54987
        • Presbyterian Medical Center
      • Jeonlabuk-do, Korea, Republic of, 54538
        • Wonkwang University School of Medicine & Hospital
      • Kyonggi-do, Korea, Republic of, 411-719
        • NHIC Ilsan Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 003-722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 01812
        • Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of, 06273
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 06973
        • Chungang University Hospital
      • Seoul, Korea, Republic of, 05278
        • Gangdong Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 07345
        • Yeouido St. Mary's Hospital
      • Suwon City, Korea, Republic of, 443-721
        • Ajou University Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Korean patients administered Kadcyla infusion at physician's discretion

Description

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

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort
Method of continuous surveillance per standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
Time Frame: Up to 8 years
Up to 8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Time Frame: Up to 8 years
Up to 8 years

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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 (Actual)

May 21, 2015

Primary Completion (Actual)

August 10, 2021

Study Completion (Actual)

August 10, 2021

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29629

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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