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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036224
Receipt No. 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

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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
Email 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
Email ni0214na@gmail.com

Sponsor
Institute Kobe Breast Cancer Oncology Group
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041267

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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