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
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
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
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
