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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000260
Receipt No. R000000326
Scientific Title Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study
Date of disclosure of the study information 2005/10/10
Last modified on 2019/03/22

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Basic information
Public title Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study
Acronym Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study(KBCSG0407 X-mono)
Scientific Title Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study
Scientific Title:Acronym Evaluation of effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer:A multicenter phase2 study(KBCSG0407 X-mono)
Region
Japan

Condition
Condition Metastatic Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness and safety of Capecitabine monotherapy in patients with Anthracycline-pretreated Metastatic Breast Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rete
Key secondary outcomes Clinical benefit rete, Progression-free survival, Overall survival, Safety profiles

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy (Capecitabine 1657mg/m2 day1-21,q4w)
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
75 years-old >=
Gender Female
Key inclusion criteria 1) Metastatic breast cancer
2) ECOG PS 0-1
3) Measurable disease as per RECIST criteria
4) No prior chemotherapy to targeted lesion
5) have Anthracycline-based regimen for pre or postoperative settings
6) Adequate bone marrow,hepatic,renal,cardiac functions
7) expected survival time: more than 6 months
8) Written informed concent
Key exclusion criteria 1) have capecitabine before
2) Hypersensitivity to drugs
3) severe complication
4) active double cancer
5) in pregnancy or lactation
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norikazu Masuda
Organization OSAKA NATIONAL HOSPITAL
Division name Surgery (Breast Oncology)
Zip code
Address 2-1-14, Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL 06-6942-1331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinzaburo Noguchi
Organization KBCSG (Kinki Breast Cancer Study Group)
Division name Executive Office
Zip code
Address 2-2, yamadaoka, suita-city, Oosaka
TEL 06-6879-3772
Homepage URL
Email

Sponsor
Institute KBCSG (Kinki Breast Cancer Study Group)
Institute
Department

Funding Source
Organization Non profit organization Epidemiological and Clinical Reserch Information Network
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

Other administrative information
Date of disclosure of the study information
2005 Year 10 Month 10 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 Completed
Date of protocol fixation
2004 Year 09 Month 09 Day
Date of IRB
2004 Year 10 Month 31 Day
Anticipated trial start date
2004 Year 11 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 10 Month 07 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000326

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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