UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037395 |
|---|---|
| Receipt number | R000042634 |
| Scientific Title | Prospective Cohort Study of Endocrine Therapy with Abemaciclib for Chemotherapy-Treated Metastatic Breast Cancer |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2024/02/01 18:11:14 |
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Basic information
Public title
Prospective Cohort Study of Endocrine Therapy with Abemaciclib for Chemotherapy-Treated Metastatic Breast Cancer
Acronym
Abemaciclib cohort study
Scientific Title
Prospective Cohort Study of Endocrine Therapy with Abemaciclib for Chemotherapy-Treated Metastatic Breast Cancer
Scientific Title:Acronym
Abemaciclib cohort study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of combination therapy with endocrine agents and abemaciclib for chemotherapy-treated metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-Free Survival
Key secondary outcomes
Overall Survival, Time to Treatment Failure, Response Rate, Clinical Benefit Rate, and Adverse Events
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
1)Women 20 years older who are diagnosed with histologically confirmed primary breast cancer.
2)Women whose breast cancer is estrogen receptor ER positive and human epidermal growth factor receptor 2 HER2 negative.
3)Women who are diagnosed with difficult to treat metastatic breast cancer.
4)Women with a history of chemotherapy after diagnosis of metastatic breast cancer.
5)Women who plan to receive treatment with abemaciclib.
6)Women who are scheduled to start abemaciclib treatment from 21 days or later after the completion of the previous chemotherapy and 14 days or later after the completion of radiotherapy.
7)Women with no recent history of treatment with CDK4/6 inhibitors.
8)Women with no previous history of treatment with abemaciclib. women with an ECOG PS of 0 2.
9)Women whose vital organ function is normal.
10)Women from whom written informed consent to participate in the study is obtained.
Women who meet any of the following exclusion criteria are excluded.
Key exclusion criteria
Exclusion Criteria
1)Women for whom endocrine therapy is not indicated.
2)Women who require oxygen inhalation because of dyspnea under resting conditions.
3)Women who have previous history of gastrectomy or small bowel resection, except for mucosal resection.
4)Women who have Crohns disease, ulcerative colitis, or chronic diarrhea of Grade 2 or higher.
5)Women who are pregnant or nursing.
6)Women undergoing treatment for bacterial or fungal infection.
7)Women who have active hepatitis B or C.
8)Women who have serious cardiac disease.
9)Women whose primary care physicians considered that they are unsuitable for inclusion in this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Narui |
Organization
Yokohama City University Medical Center
Division name
Breast and Thyroid Surgery
Zip code
232-0024
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024
TEL
045-261-5656
nr1@gc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Narui |
Organization
Yokohama City University Medical Center
Division name
Breast and Thyroid Surgery
Zip code
232-0024
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024
TEL
045-261-5656
Homepage URL
nr1@gc5.so-net.ne.jp
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
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
Yokohama City University Medical Center
Address
4-57 Urafune, Minami-ku, Yokohama 232-0024
Tel
045-261-5656
nr1@gc5.so-net.ne.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
| 2019 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://cspor-bc.or.jp/members/abemaciclib/
Publication of results
Unpublished
Result
URL related to results and publications
https://cspor-bc.or.jp/members/abemaciclib/
Number of participants that the trial has enrolled
180
Results
Under analyzing
Results date posted
| 2024 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Under analyzing
Participant flow
Under analyzing
Adverse events
Under analyzing
Outcome measures
Under analyzing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional, minimally invasive, prospective observational study
Management information
Registered date
| 2019 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042634
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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