UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043917 |
|---|---|
| Receipt number | R000050098 |
| Scientific Title | Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer |
| Date of disclosure of the study information | 2021/04/14 |
| Last modified on | 2021/04/14 07:35:40 |
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Basic information
Public title
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Acronym
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Scientific Title
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Scientific Title:Acronym
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/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
1)Time to treatment failure
2)Overall survival
3)Objective response rate
4)Clinical benefit rate
5)Parcentage of participants with over Grade 3 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
Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer patients who have completed postoperative hormone therapy for more than 1 year or who have not been treated with hormone therapy and who meet all of the following criteria are included.
1) Histologically confirmed advanced/metastatic breast cancer
2) Premenopausal or postmenopausal patients aged 20 years or older
3) Confirmed diagnosis of ER positive breast cancer
4) Confirmed diagnosis of HER2 negative breast cancer
5) Adequate organ and bone marrow function
6) Easter Cooperative Oncology Group [ECOG]0-1
7) No prior systemic chemotherapy or 1st line prior systemic chemotherapy
8) Signed written informed consent
Key exclusion criteria
1) Recurrence during postoperative hormone therapy or within 1 year from completion of treatment
2) Known uncontrolled or symptomatic central nervous system metastases
3) Patients with advanced symptomatic visceral spread that are at risk of life threatening complication in the short term
4) Prior endocrine therapy for advanced/metastatic breast cancer
5) Known interstitial lung disease on imaging
6) Known uncontrolled infection
7) Current pregnancy and lactation or possibility of pregnancy
8) Known drug allergy to any of study drugs
9) Assessment by investigator that subject unable to comply with protocol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Mizuno |
Organization
Yokkaichi Municipal Hospital
Division name
Breast Surgery
Zip code
510-8567
Address
2-2-37 Shibata Yokkaichi-city Mie
TEL
059-354-1111
mizunoy729@yokkaichihp01.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Mizuno |
Organization
Yokkaichi Municipal Hospital
Division name
Breast Surgery
Zip code
510-8567
Address
2-2-37 Shibata Yokkaichi-city Mie
TEL
059-354-1111
Homepage URL
mizunoy729@yokkaichihp01.jp
Sponsor or person
Institute
Breast Surgery, Yokkaichi Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Breast Surgery, Yokkaichi Municipal Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Yokkaichi Municipal Hospital
Address
2-2-37 Shibata Yokkaichi-city Mie
Tel
059-354-1111
chiken@yokkaichihp01.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 | 04 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050098
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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