UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000017702
Receipt No. R000016838
Scientific Title KADCYLA drug use surveillance
Date of disclosure of the study information 2015/05/27
Last modified on 2019/04/05 (Ver. 13)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title KADCYLA drug use surveillance
Acronym KADCYLA drug use surveillance
Scientific Title KADCYLA drug use surveillance
Scientific Title:Acronym KADCYLA drug use surveillance
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Endocrinology and Metabolism Hematology and clinical oncology Endocrine surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety
- Understand the onset profile of adverse drug reactions (selected adverse event: platelet count decreased, impaired liver function)
- Find unexpected adverse drug reactions
- Understand factors that may affect the safety of KADCYLA
To assess the effectiveness
- Understand response rate based on evaluation by attending physicians
- Understand factors that may affect the effectiveness of KADCYLA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety;ADR occurence
Key secondary outcomes Efficacy;Response rate per investigator assessment

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with breast cancer who are scheduled to start receiving KADCYLA during this surveillance enrollment period at the first time.
Key exclusion criteria No criteria
Target sample size 250

Research contact person
Last name of lead principal investigator
1st name Izumi
Middle name
Last name Kawshima
Organization Chugai Pharmaceutical Co., Ltd.
Division name Real World Data Science Dept.
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0769
Email kawashmaizm@chugai-pharm.co.jp

Public contact
1st name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co., Ltd.
Division name Real World Data Science Dept.
Zip code 103-8324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Not applicable for Drug use surveillance
Address Not applicable for Drug use surveillance
Tel Not applicable for Drug use surveillance
Email Not applicable for Drug use surveillance

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 27 Day

Related information
URL releasing protocol Not opened
Publication of results Unpublished

Result
URL related to results and publications Not opened
Number of participants that the trial has enrolled 250
Results 
The adverse drug reaction incidence rate in 250 examples of safety analysis was 69.60% (174/ 250 example), and the case number was 438, and platelet decreased number 54.40% (136/250 examples), aspartic acid AMINOTORANSUFERAZE increased 31.20 % (78/250 examples), ARANINAMINOTORANSUFERAZE increased 20.00 % (50/250 examples), liver function abnormal 8.00 % (20/250 examples) and nose bleeding 6.80 % (17/250 examples) met main adverse drug reactions (5% or more than of adverse drug reaction incidence rate).
Results date posted
2019 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patient were all women and a pregnant woman wasn't included. By age basis, more than 15 years old, less than 65 years old, 60.00% (150/250 examples) and more than 65 years old, 40.00 % (100/250 examples) came.
Participant flow 
258 patients of CRF were collected. Of these 250 pts were analysed for a safety analysis set.
Adverse events 
The adverse drug reaction incidence rate in 250 examples of safety analysis was 69.60% (174/ 250 example), and the case number was 438, and platelet decreased number 54.40% (136/250 examples), aspartic acid AMINOTORANSUFERAZE increased 31.20 % (78/250 examples), ARANINAMINOTORANSUFERAZE increased 20.00 % (50/250 examples), liver function abnormal 8.00 % (20/250 examples) and nose bleeding 6.80 % (17/250 examples) met main adverse drug reactions (5% or more than of adverse drug reaction incidence rate).
Outcome measures 
This surveillance will collect information on the following aspects of the use of KADCYLA under post-marketing conditions. 
(1)	Adverse drug reactions (events of interest: febrile neutropenia, interstitial lung disease)
(2)	Unknown adverse drug reactions
(3)	Response rate, as assessed by the attending physician
(4)	Factors thought to affect safety or efficacy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 17 Day
Date of IRB
2014 Year 04 Month 17 Day
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patient baseline characteristics, Treatment history of primary disease, Concomitant drugs, Combination therapy, Outcome, Adverse events

Management information
Registered date
2015 Year 05 Month 27 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016838