UMIN-CTR Clinical Trial

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

Local advanced and recurrent metastatic breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

progression free survival

Key secondary outcomes

clinical benefit
overall survival

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo college of Medicine

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Kansai Rosai Hospital
Yao Municipal Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

02

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2019

Year

02

Month

04

Day

Last modified on

2020

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040558