UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013002
Receipt number R000015176
Scientific Title Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)
Date of disclosure of the study information 2014/01/29
Last modified on 2016/02/08 09:15:56

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Basic information

Public title

Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Acronym

Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Scientific Title

Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Scientific Title:Acronym

Cohort study evaluating efficacy and safety of gemcitabine for advanced or metastatic breast cancer (YCOG1005)

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify efficacy and safety of gemcitabine (single agent administration) for advanced or metastatic breast cancer with prospective cohort study.

Basic objectives2

Others

Basic objectives -Others

Health related quolity of life.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to Treatment failure,TTF

Key secondary outcomes

adverse event, QOL(FACT-B)


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

80 years-old >

Gender

Female

Key inclusion criteria

1) Patients have been confirmed with breast cancer histologically or cytologically
2) ECOG preformance status (PS.): 0-2.
3) Sufficient bone marrow and major organ functions (determined by the attending physician).
4) Extent of radiation therapy being 20% or below of whole bone marrow.
5) Study treatment is the first line chemotherapy in inoperable metastatic breast cancer.
6)Written informed consent.

Key exclusion criteria

1) Past history of gemcitabine administration.
2) Inflamatory breast cancer
3) Pulmonary fibrosis or interstitial pneumonia.
4) Heart failure or acute myocardiac infarction within 6 months.
5) Active infection.
6) Severe complications.
7) Severe drug allergy.
8) Severe psychiatric disorder.
9) Symptomatic brain betastasis
10) Double cancer.
11) Women who are pregnant, lactating or declined contraception.
12) Gastrointestinal perforation and severe fistula

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Ishikawa

Organization

Yokohama City University Medical Center

Division name

Department of Breast and Thyroid Surgery

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Email

tishik@urahp.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazutaka Narui

Organization

Yokohama City University Medical Center

Division name

Department of Breast and Thyroid Surgery

Zip code


Address

4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan

TEL

045-261-5656

Homepage URL


Email

nr1@gc5.so-net.ne.jp


Sponsor or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
藤沢市民病院(神奈川県)
横須賀市立市民病院(神奈川県)
湘南記念病院(神奈川県)
横浜市立市民病院(神奈川県)
横浜市立みなと赤十字病院(神奈川県)
横須賀共済病院(神奈川県)
伊東市民病院(神奈川県)
済生会横浜市南部病院(神奈川県)
国立病院機構横浜医療センター(神奈川県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2010 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is to clarify efficacy and safety of gemcitabine (single agent administration) for advanced or metastatic breast cancer with prospective cohort study. Health related quolity of life (HRQoL) is assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire.
Registration started in June 2010.


Management information

Registered date

2014 Year 01 Month 29 Day

Last modified on

2016 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015176


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name