UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035533 |
|---|---|
| Receipt number | R000040483 |
| Scientific Title | Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study |
| Date of disclosure of the study information | 2019/01/13 |
| Last modified on | 2023/01/29 12:50:37 |
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Basic information
Public title
Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Acronym
SBP-11
Scientific Title
Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Scientific Title:Acronym
SBP-11
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 the safety of fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS
Key secondary outcomes
CBR, OS, ORR, TTF, Safety, compliance
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
Locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer pretreated with no hormonal therapy for MBC.
1 Adaptation for Fulvestrant and CDK4/6 inhibitor and the informed consent is obtained.
2 age >=20,female, regardless of menstrual status.
3 locally advanced/ metastatic breast cancer histologically confirmed
4 Hormone receptor positive breast cance confirmed by Immunohistochemically.
5 HER2 negative breast cance confirmed by Immunohistochemically or ISH.
6 ECOG PS: 0-2
7 non-hematological AE( CTCAE v4.0-JCOG) <= grade 2
7 no major organ dysfunction nor bone marrow dysfunction.
8 with or without evaluable lesions (with evaluable lesions preferred)
9 1st line hormonal therapy for MBC ( 1regimen fo chemotherapy is allowed)
10 with documented informed consent.
Key exclusion criteria
1 with life-threatenings
2 symptomatic brain metastasis
3 eligible for inclusion criteria of PALOMA-3
4 pretreated with hormonal therapy for MBC
5 pregnancy or breast feeding or unwilling to contraception
6 long QT syndrome or similar diseases
7 Electrolyte abnormality causing long QT syndrome
8 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months
9 obvious pulmonary fibrosis or interstitial pneumonia
10 active infection
11 other severe comorbidity
12 another active cancer
13 allergic for fulvestrant or CDK4/6 inhibitor
14 other inappropriate patients
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kubo |
Organization
Fukuyama City Hospital
Division name
Department of Breast and thyroid surgery
Zip code
721-08511
Address
5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL
084-941-5151
kubokubobo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naruto |
| Middle name | |
| Last name | Taira |
Organization
Setouchi Breast Project Comprehensive Support Organization
Division name
Clinical trial committee
Zip code
700-8558
Address
2-5-1, Shikata, Kita-ku, Okayama,Japan
TEL
086-235-7265
Homepage URL
info@setouchi-bp.com
Sponsor or person
Institute
Setouchi Breast Project Comprehensive Support Organization
Institute
Department
Personal name
Funding Source
Organization
Setouchi Breast Project Comprehensive Support Organization
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Fukuyama City Hospital
Address
5-23-1 Zao-cho, Fukuyama city , Hiroshisma,Japan
Tel
084-941-5151
shimin-byouin@city.fukuyama.hiroshima.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 | 01 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
clinical data
Management information
Registered date
| 2019 | Year | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040483
| 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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