Clincosm LogoSign in Get a demo

An Observational Study of Kadcyla Safety in Breast Cancer

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT02305641
Collaborator
(none)
563
Enrollment
39
Locations
74.7
Actual Duration (Months)
14.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    563 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post-Marketing Surveillance of Kadcyla in Breast Cancer
    Actual Study Start Date :
    May 21, 2015
    Actual Primary Completion Date :
    Aug 10, 2021
    Actual Study Completion Date :
    Aug 10, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort

    Method of continuous surveillance per standard of care

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Inje University Busan Paik Hospital Busan Korea, Republic of 47392
    2 Dong-A University Hospital Busan Korea, Republic of 49201
    3 Pusan National University Hospital Busan Korea, Republic of 49241
    4 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    5 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404
    6 Keimyung University Dongsan Medical Center Daegu Korea, Republic of 41931
    7 Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion Daegu Korea, Republic of
    8 The Catholic University of Korea Daejeon ST. Mary's Hospital Daejeon Korea, Republic of 34943
    9 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    10 Uijeongbu St. Mary's Hospital Gyeonggi-do Korea, Republic of 11765
    11 Hallym University Sacred Heart Hospital Gyeonggi-do Korea, Republic of 14068
    12 Soonchunhyang University Bucheon Hospital Gyeonggi-do Korea, Republic of 14584
    13 Bucheon St Mary's hospital Gyeonggi-do Korea, Republic of 14647
    14 St. Vincent's Hospital Gyeonggi-do Korea, Republic of 16247
    15 Pusan National University Yangsan Hospital Gyeongsangnam-do Korea, Republic of 50612
    16 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    17 Inha University Hospital Incheon Korea, Republic of 22332
    18 Catholic Kwandong University International St. Mary'S Hospital. Incheon Korea, Republic of
    19 Chonbuk National Uni Hospital Jeollabuk-do Korea, Republic of 561-712
    20 Chonnam National University Hwasun Hospital Jeollanam-do Korea, Republic of 58128
    21 Presbyterian Medical Center Jeonju-si Korea, Republic of 54987
    22 Wonkwang University School of Medicine & Hospital Jeonlabuk-do Korea, Republic of 54538
    23 NHIC Ilsan Hospital Kyonggi-do Korea, Republic of 411-719
    24 Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences Seoul Korea, Republic of 01812
    25 Korea University Anam Hospital Seoul Korea, Republic of 02841
    26 Seoul National University Hospital Seoul Korea, Republic of 03080
    27 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    28 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    29 Konkuk University Medical Center Seoul Korea, Republic of 05030
    30 Gangdong Kyung Hee University Hospital Seoul Korea, Republic of 05278
    31 Asan Medical Center Seoul Korea, Republic of 05505
    32 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    33 Samsung Medical Center Seoul Korea, Republic of 06351
    34 ChungAng University Hospital Seoul Korea, Republic of 06973
    35 Yeouido St. Mary's Hospital Seoul Korea, Republic of 07345
    36 Ewha Womans University Mokdong Hospital Seoul Korea, Republic of 07985
    37 SMG-SNU Boramae Medical Center Seoul Korea, Republic of 156-707
    38 Ajou University Hospital Suwon City Korea, Republic of 443-721
    39 Ulsan University Hosiptal Ulsan Korea, Republic of 44033

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT02305641
    Other Study ID Numbers:
    • ML29629
    First Posted:
    Dec 2, 2014
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 21, 2022