UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056579 |
|---|---|
| Receipt number | R000064652 |
| Scientific Title | A Multi-Country Real-World Evidence Study Characterising Patients and Abemaciclib Persistence at 6 Months of Treatment in HR+, HER2- High-Risk Early Breast Cancer (Abema EBC) |
| Date of disclosure of the study information | 2024/12/27 |
| Last modified on | 2024/12/26 13:46:56 |
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Basic information
Public title
A Multi-Country Real-World Evidence Study Characterising Patients and Abemaciclib Persistence at 6 Months of Treatment in HR+, HER2- High-Risk Early Breast Cancer (Abema EBC)
Acronym
Abema EBC
Scientific Title
A Multi-Country Real-World Evidence Study Characterising Patients and Abemaciclib Persistence at 6 Months of Treatment in HR+, HER2- High-Risk Early Breast Cancer (Abema EBC)
Scientific Title:Acronym
Abema EBC
Region
| Japan | South America | Europe |
Condition
Condition
Early Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this project is to collect real-world data on abemaciclib use in early breast cancer patients in Spain, France, the UK, Japan and Brazil.
Basic objectives2
Others
Basic objectives -Others
Primary objectives
1. To describe the proportion of patients with early breast cancer receiving abemaciclib who remain on abemaciclib treatment after 6 months following treatment start.
2. To describe the demographic and clinical characteristics of patients with early breast cancer up to initiation of abemaciclib.
Secondary objectives
1. To describe treatment patterns of abemaciclib and combination hormonal therapy in patients with early breast cancer.
2. To describe the treatments that patients with early breast cancer received prior to and following abemaciclib treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.
i. Proportion of patients still receiving abemaciclib treatment 6 months after starting treatment.
ii. Proportion of patients who discontinue abemaciclib over the first 6 months and reasons for discontinuation.
2.
i. Demographic characteristics at abemaciclib start.
ii. Clinical characteristics up to abemaciclib start.
Key secondary outcomes
Secondary endpoints
1
i. Summary of the treatment duration of abemaciclib over the study period.
ii. Proportion of patients who remain on abemaciclib at 30 days and 3 months following treatment start.
iii. Proportion of patients who discontinue abemaciclib and reasons for discontinuation over the entire follow-up period.
iv. Dose changes following treatment start and reasons for change.
v. Starting combination hormonal agent and starting dose of combination hormonal therapy.
vi. Proportion of patients who remain on combination hormonal therapy 6 months after starting abemaciclib treatment.
2
i. Description of surgery received prior to and following abemaciclib, overall and by type of surgery, and outcomes following surgery.
ii. Description of hormonal, chemotherapy, and other treatments received prior to and following abemaciclib + combination hormonal agent, overall and by drug.
iii. Description of radiotherapy received prior to and following abemaciclib.
iv. Description of the time from definitive breast cancer surgery to adjuvant treatment start.
v. Description of the time from definitive breast cancer surgery to abemaciclib treatment start.
vi. Description of the time from start of combination adjuvant endocrine therapy to abemaciclib start.
vii. Description of the time from the start of adjuvant chemotherapy to abemaciclib treatment start.
viii. Description of the time from the start of adjuvant radiotherapy to abemaciclib treatment start.
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
Female
Key inclusion criteria
1.Provision of patient informed consent (or consent from next of kin/legal representative, if applicable) for use of patients' secondary data or appropriate informed consent waiver according to local regulations.
2.Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative patients with early breast cancer at high-risk of recurrence receiving abemaciclib following surgery.
a. Early-stage breast cancer is defined as no record of stage IV or metastatic disease from breast cancer diagnosis date to abemaciclib start date.
b. For patients enrolled in France, UK, Spain and Japan, the definition of high-risk is:
i. either >=4 positive axillary lymph nodes (pALN),
ii. or 1-3 pALN and at least one of the following criteria: tumour size >=5 cm or histological grade 3.
c. For patients enrolled in Brazil, the definition of high-risk is:
i. either >=4 positive axillary lymph nodes (pALN),
ii. or 1-3 pALN and at least one of the following criteria: tumour size >=5 cm or histological grade 3,
iii. or 1-3 pALN and Ki67 index >=20%.
3.Patients receiving a starting dose of abemaciclib of 150 mg twice per day in combination with an aromatase inhibitor or tamoxifen.
Key exclusion criteria
1. Patients who received treatment with abemaciclib as part of a clinical trial.
2. Patients who received abemaciclib as part of an early access programme.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3781-8146
sakai-h@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Sakai |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3781-8146
Homepage URL
sakai-h@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
IQVIA
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-u.ac.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
| 2024 | Year | 12 | Month | 27 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multi-country, multi-centre, retrospective observational study comprising both chart abstraction (Japan, Brazil) and electronic medical records (EMR) data extraction, with manual data enhancement, if required (Spain, France, and UK). EMR data extraction will occur at sites within IQVIA's Oncology Evidence Network (OEN) as well as any other site with the capability to perform EMR extraction. Data will be abstracted / extracted from the date of initial breast cancer diagnosis to medical records abstraction initiation date, which will be country-specific and depend on when the first site in each country is activated. The eligibility period will start 6 months after the country-specific drug availability date to allow centers centres to gain confidence in the utilizationutilisation of abemaciclib as per label in the early breast cancer indication, and continue until 6 months prior to the medical records abstraction initiation date (other than Spain, where the eligibility period will end on 30-Apr15-Jul-2024 to avoid overlap between this study and a local initiative also enrolling patients receiving abemaciclib). The index date will be the date on which patients start abemaciclib. All patients whose index date falls within the eligibility period and who meet all inclusion / exclusion criteria will be enrolled into the study. If a site has more eligible patients available than the quota for that site, sites will be instructed to select patients consecutively from the start of the in-country eligibility period based on index date (i.e. the patient with index date closest to the start of the eligibility period will be selected first, followed by the patient with the next closest index date etc.).
Management information
Registered date
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064652
