UMIN-CTR Clinical Trial

Basic information
Public title	Identification of prognostic factors in locally advanced and recurrent patients (multicenter collaborative research)
Acronym	Identification of prognostic factors in locally advanced and recurrent breast cancer patients
Scientific Title	Identification of prognostic factors in locally advanced and recurrent patients (multicenter collaborative research)
Scientific Title:Acronym	Identification of prognostic factors in locally advanced and recurrent breast cancer patients
Region	Japan

Condition
Condition	Local advanced and recurrent metastatic breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prognosis of recurrent breast cancer has improved with progress of therapeutic drugs. However, in what order is it most effective to use many drugs, this point is not clear. In estrogen receptor positive breast cancer, generally, starting with endocrine therapy, it shifts to chemotherapy when treatment effect is no longer available. However, some cases progress rapidly and there are cases where timing to perform chemotherapy is lost, so detecting the prognosis in recurrent patients is useful for treatment selection. Therefore, the purpose of this study is to identify prognostic factors and therapeutic effect predictive factors for locally advanced and recurrent breast cancer patients.
Basic objectives2	Others
Basic objectives -Others	The data to be examined this time are image data, clinical examination data, treatment effect, prognosis etc. to be carried out in routine practice. The above data is extracted from medical record. The period for collecting information is five years of this research period. The subject of this survey is about 200 cases treated by Hyogo College of Medicine for local progression or recurrence. From the collaborative research institute, 100 cases are scheduled. This study is expected to identify factors that influence the prognosis and therapeutic effect of recurrent patients, and the results provide useful information in selecting treatment methods in routine practice.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	clinical benefit overall survival

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients undergoing treatment for locally advanced and recurrent breast cancer at Hyogo college of Medicine and collaborative research institutions and patients who will be receiving research in the future
Key exclusion criteria	Data missing cases
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name yasuo miyoshi
Organization	Hyogo college of Medicine
Division name	Breast and endocrine surgery
Zip code
Address	1-1,Mukogawacho, Nishinomiya-city,Hyogo
TEL	0798-45-6374
Email	ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name yasuo miyoshi
Organization	Hyogo college of Medicine
Division name	Breast and endocrine surgery
Zip code
Address	1-1,Mukogawacho, Nishinomiya-city,Hyogo
TEL	0798-45-6374
Homepage URL
Email	ymiyoshi@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kansai Rosai Hospital Yao Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications	Anticancer Res. 2019 Oct;39(10):5653-5662
Number of participants that the trial has enrolled	100
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	2017 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date	2017 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The data to be used is data such as image, clinical examination, treatment effect, prognosis etc. to be carried out in routine practice. They are extracted from medical record. This study is expected to be able to identify factors affecting the prognosis and therapeutic effect of recurrent patients, and the results provide useful information for selecting treatment methods in routine practice.

Management information
Registered date	2019 Year 02 Month 04 Day
Last modified on	2020 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040558