UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036224 |
|---|---|
| Receipt number | R000041267 |
| Scientific Title | Safety and efficacy of Palbociclib in combination with endocrine therapy in ER-positive HER2-negative advanced breast cancer-multi-institutional retrospective study -KBCOG-14 |
| Date of disclosure of the study information | 2019/03/20 |
| Last modified on | 2019/03/18 17:25:42 |
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Basic information
Public title
Safety and efficacy of Palbociclib in combination with
endocrine therapy in ER-positive HER2-negative
advanced breast cancer-multi-institutional
retrospective study -KBCOG-14
Acronym
Safety and efficacy of Palbociclib in co
mbination with endocrine therapy in ER-positive HER2-
negative advanced breast cancer-KBCOG-14
Scientific Title
Safety and efficacy of Palbociclib in combination with
endocrine therapy in ER-positive HER2-negative
advanced breast cancer-multi-institutional
retrospective study -KBCOG-14
Scientific Title:Acronym
Safety and efficacy of Palbociclib in combination with
endocrine therapy in ER-positive HER2-negative
advanced breast cancer- KBCOG-14
Region
| Japan |
Condition
Condition
ER-positive HER2-negative advanced breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect real-world data of Palbocicilib in practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PFS
OS
Adverse events
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1)advanced/metastatic breast cancer patients
2)ER positive and/or PgR positive, HER2 negative in
primary or metastatic lesion
3)treated by Palbociclib with endocrine therapy for more
than 1 week between December in 2017 and December in
2018.
Key exclusion criteria
treated by Palbociclib with endocrine therapy for less
than 1 week
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Takao |
Organization
Hyogo Cancer Center
Division name
Breast Surgery
Zip code
6738558
Address
13-70 kitaoji-cho akashi, Japan
TEL
078-929-1151
s.tkao@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Nina |
| Middle name | |
| Last name | Odan |
Organization
Shinko Hospital
Division name
Breast Surgery
Zip code
651-0072
Address
1-4-47 wakihama-cho chuo-k u kobe, Japan
TEL
078-261-6711
Homepage URL
ni0214na@gmail.com
Sponsor or person
Institute
Kobe Breast Cancer Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Kobe Breast Cancer Oncology Group
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
Hyogo Cancer Center IRB
Address
13-70 kitaoji-cho akashi, Japan
Tel
078-929-1151
rinsyoshikenkanri6@hyogo-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
兵庫県立がんセンター
神戸大学附属病院 乳腺内分泌外科
神戸中央市民病院 乳腺外科
西神戸医療センター 乳腺外科
神鋼病院 乳腺外科
尼崎総合医療センター 乳腺外科
伊川谷病院 乳腺外科
明和病院 乳腺外科
甲南病院 外科
橋本クリニック
淀川キリスト教病院 乳腺外科
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 20 | 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 | 22 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
We analyzed the data from CRF collected in the electric
record review in the individual institutes.
Management information
Registered date
| 2019 | Year | 03 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041267
