UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013045
Receipt number R000015223
Scientific Title Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.
Date of disclosure of the study information 2014/02/03
Last modified on 2014/02/02 20:05:02

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Basic information

Public title

Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.

Acronym

Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.

Scientific Title

Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.

Scientific Title:Acronym

Patient preference trial comparing capecitabine and S-1 in metastatic breast cancer patients.

Region

Japan


Condition

Condition

metastatic breast carcinoma

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

patient preference

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

patient preference

Key secondary outcomes

PFS, OS, address quality of life (EORTC-30), and anxiety and depression (HADS)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

capecitabine

Interventions/Control_2

S-1

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

25 years-old <

Age-upper limit

75 years-old >

Gender

Female

Key inclusion criteria

metastatic breast cancer patient

Key exclusion criteria

ECOG performance status is more than 3

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daigo Yamamoto

Organization

kansai Medical University

Division name

breast unit

Zip code


Address

fumizono-cho 10-15

TEL

0669921001

Email

yamamotd@takii.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daigo Yamamoto

Organization

JBCRN

Division name

breast unit

Zip code


Address

fumizono-cho 10-15

TEL

0669921001

Homepage URL


Email

yamamotd@takii.kmu.ac.jp


Sponsor or person

Institute

Japan Breast Cancer Research Network

Institute

Department

Personal name



Funding Source

Organization

Japan Breast Cancer Research Network

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

東京大学 弘前大学 星光病院 ナグモクリニック 東北大学


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 03 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

Preinitiation

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 02 Month 02 Day

Last modified on

2014 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name