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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000517
Receipt No. R000000626
Scientific Title Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Date of disclosure of the study information 2006/11/09
Last modified on 2019/11/21

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Basic information
Public title Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Acronym Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Scientific Title Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Scientific Title:Acronym Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Region
Japan

Condition
Condition Reccurent or metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of a combination chemotherapy with CPT-11 and S-1 in recurrent or metastatic breast cancer patients with prior chemotherapy with anthracycline and taxane
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between adverse effects and efficacy and UGT1A1 polymorophism
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I:MTD, DLT, RD
Phase II:Clinical response, Clinical efficacy
Key secondary outcomes Phase II:Adverse events, TTP, OS

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
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 Male and Female
Key inclusion criteria Reccurent, metastatic breast cancer
Previous anthracycline, taxane
Her 2 negative
PS 0-2
Adequate organ function
Informed consent
Key exclusion criteria Prior chemotherapy with CPT-11, S-1
Diarrhea
No lesion other than bone metastasis
Brain metastasis
Serious cardiac disease
Target sample size 49

Research contact person
Name of lead principal investigator
1st name Masakazu
Middle name
Last name Toi
Organization Graduate School of Medicine Kyoto University
Division name Department of Surgery (Breast Surgery)
Zip code 606-8507
Address 54 Kawara-cho Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan
TEL 075-751-3660
Email toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Head office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL https://jbcrg.jp/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization ACRO
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization JBCRG
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel 03-6264-8873
Email office@jbcrg.jp

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 東京都立駒込病院(東京都)、京都大学医学部附属病院(京都府)、愛知県がんセンター中央病院(愛知県)、埼玉医大国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially 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
2006 Year 06 Month 23 Day
Date of IRB
2006 Year 07 Month 10 Day
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2011 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Presentation: 17th Annual Meeting of the Japanese Breast Cancer Society(2009)

Management information
Registered date
2006 Year 11 Month 09 Day
Last modified on
2019 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000626

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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