UMIN-CTR Clinical Trial

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
Last 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
1st 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