UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043149 |
|---|---|
| Receipt number | R000049256 |
| Scientific Title | The Real-World Data of Treatment with Abemaciclib for HR-positive HER2-negative Metastatic Breast Cancer: A Multicentral Cohort Study |
| Date of disclosure of the study information | 2021/01/27 |
| Last modified on | 2023/07/31 09:52:33 |
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Basic information
Public title
The Real-World Data of Treatment with Abemaciclib for HR-positive HER2-negative Metastatic Breast Cancer: A Multicentral Cohort Study
Acronym
Observational study on HR+/HER2- Mestastatic Breast Cancer patients treated with Abemaciclib. Chart Review
Scientific Title
The Real-World Data of Treatment with Abemaciclib for HR-positive HER2-negative Metastatic Breast Cancer: A Multicentral Cohort Study
Scientific Title:Acronym
The Real-World Data of Treatment with Abemaciclib for HR-positive HER2-negative Metastatic Breast Cancer: A Multicentral Cohort Study
Region
| Japan | Europe |
Condition
Condition
HR-positive HER2-negative Metastatic Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The general objective of this study is to describe patient demographic and clinical characteristics and treatment patterns, including previous treatments for breast cancer, of female patients with HR+/HER2- locally advanced/metastatic breast cancer who started treatment with regimens that include Abemaciclib.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to describe patient demographic and clinical characteristics and treatment patterns, including previous treatments for breast cancer, of female patients with HR+/HER2- locally advanced/metastatic breast cancer who started treatment with regimens that include Abemaciclib.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients eligible for inclusion in this study must fulfill all the following criteria:
Female patients >18 with a confirmed diagnosis of HR+/Her2- metastatic breast cancer (stage IIIb, IIIc or IV), as defined in the relevant American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP)
Guidelines (Wolff et al., 2007; Hammond et al., 2010)
Started treatment with regimes that include abemaciclib, and have been followed for at least three months after abemaciclib initiation, independently of abemaciclib maintenance.
Key exclusion criteria
Participation in a clinical trial any time after the initiation of abemaciclib treatment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Nozawa |
Organization
Aichi Cancer Center Hospital
Division name
Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
0527646111
k.nozawa@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nozawa |
Organization
Aichi Cancer Center Hospital
Division name
Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan.
TEL
0527646111
Homepage URL
k.nozawa@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan
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
Institutional Review Board of Aichi Cancer Center Hospital
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan.
Tel
0527646111
irb@aichi-cc.jp
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
| 2021 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12282-023-01461-6
Number of participants that the trial has enrolled
200
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
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
A Multicentral Cohort Study
Management information
Registered date
| 2021 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049256
