UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000517 |
|---|---|
| Receipt number | 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 | 2021/08/17 09:25:02 |
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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
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/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
12
Results
DLT was grade 4 hematological toxicity and grade 3>= nonhematological toxicities.
Recommended dose for phase II were CPT-11 100mg/m2, TS-1 80-120mg/day.
Results date posted
| 2021 | Year | 08 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2009 | Year | 07 | Month | 03 | Day |
Baseline Characteristics
Recurrent or metastatic HER2-negative breast cancer previously treated with anthracyclines and taxanes.
Participant flow
12 patients were enrolled in this Phase 1 study (metastatic 4, recurrence 8).
Adverse events
Diarrhea, alopecia, neutropenia were common adverse events.
Outcome measures
maximum tolerated dose (MTD), dose-limiting toxicities (DLTs),
recommended dose (RD).
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
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000626
