UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049797 |
|---|---|
| Receipt number | R000056710 |
| Scientific Title | A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2022/12/15 18:49:03 |
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Basic information
Public title
A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib
Acronym
Abemaciclib Chart Review Study 2
Scientific Title
A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib
Scientific Title:Acronym
A Multinational Observational Study Characterizing Utilization and Effectiveness Outcomes in Patients with Metastatic Breast Cancer Receiving Abemaciclib
Region
| Japan | Europe |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this non-interventional study (NIS) is to describe treatment effectiveness in patients receiving abemaciclib in HR positive HER2 negative ABC as per label, by line of treatment including abemaciclib, across 6 countries including France, Germany, Italy, Japan, Spain, and United Kingdom (UK).
The operational objectives are:
1. To describe PFS
2. To describe time to first subsequent therapy (TFST) and time to second progression (PFS2)
3. To describe overall response rate (ORR)
4. To describe clinical benefit rate (CBR)
5. To describe the time to and reasons for t
Basic objectives2
Others
Basic objectives -Others
NA
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
PFS, TFST, ORR, CBR
Key secondary outcomes
population, index date, OS
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
The patient population that will be selected and observed in the study must fulfil all the following criteria:
1. Provision of subject informed consent (or consent from next of kin/legal representative, if applicable) for use of the data and according to local regulations
2. Adult patients (age of majority in the country of interest)
3. Patient with histologically confirmed HR+/HER2- ABC by physician
4. Patients who initiated treatment with abemaciclib (combination therapy) between in country drug availability and 31st December 2021.
Key exclusion criteria
1. Patients who received treatment with abemaciclib as part of a clinical trial
2. Patients who participated in a clinical trial any time after the initiation of abemaciclib treatment
3. Patients who benefited from an early access program for abemaciclib treatment
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Mitsuo |
| Middle name | |
| Last name | Terada |
Organization
Nagoya City University Hospital
Division name
Breast Surgery
Zip code
467-8602
Address
1 Kawasumi, Mizuho-ku, Nagoya City, Aichi
TEL
052-851-5511
tsurutaj@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Tsurutani |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa, Tokyo
TEL
03-33784-8145
Homepage URL
tsurutaj@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Faculty of Medicine
Address
1 Kawasumi, MIzuho, Mizuho, Nagoya, Aichi
Tel
052-853-8545
NA@NA
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
| 2022 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056710
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| Registered date | File name |
| Research case data | |
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