UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000563 |
|---|---|
| Receipt number | R000000679 |
| Scientific Title | Study of letrozole in postmenopausal patients with breast cancer (JBCRG M02) |
| Date of disclosure of the study information | 2006/12/27 |
| Last modified on | 2021/08/06 11:10:11 |
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Basic information
Public title
Study of letrozole in postmenopausal patients with breast cancer (JBCRG M02)
Acronym
JBCRG-M02
(Study of letrozole in postmenopausal patients with breast cancer)
Scientific Title
Study of letrozole in postmenopausal patients with breast cancer (JBCRG M02)
Scientific Title:Acronym
JBCRG-M02
(Study of letrozole in postmenopausal patients with breast cancer)
Region
| Japan |
Condition
Condition
Postmenopausal patients with breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of letrozole in postmenopausal patients with metastatic or locally advanced breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical responce rate by hormone receptor status (Allred score) and Her2 status
Key secondary outcomes
Time to progression, advertse events, expression of hormone receptor-related factors
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
Letrozole 2.5 mg/day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Postmenopausal women
Metastatic or locally advanced breast cancer
Hormone receptor positive breast cancer
Measureable lesion
Adequate organ function
PS 0-2
Written informed concent
Key exclusion criteria
Inflammatory breast cancer
Lymphangitic lung metastasis
Brain metastasis
Diffuse liver metastasis
Active double cancer
Prior aromatase inhibitors within one year
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsumasa |
| Middle name | |
| Last name | Kuroi |
Organization
Metropolitan Komagome Hospital
Division name
Surgery Dept
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677 Japan
TEL
03-3823-2101
kurochan@dd.iij4u.or.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
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://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
Funding Source
Organization
Japan Breast Cancer Research Group (JBCRG)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Breast Cancer Research Group (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
市立堺病院（大阪府）、広島市立安佐市民病院（広島県）、八尾市立病院（大阪府）、四国がんセンター（愛媛県）、名古屋市立東市民病院（愛知県）、大阪医療センター（大阪府）、都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
50
Results
CR2, PR16, SD over 24 weeks 20, PD1
Results date posted
| 2021 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age 64.6; locally advanced 3, recurrent 30, metastatic 14, unknown 3 ; Soft tissue only 16, visceral 26, bone only 5, unknown 3
Participant flow
Treatment, clinical evaluation n=50
Adverse events
Grade 3,4 2(4%)
Outcome measures
Clinical response, adverse effect
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2006 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2007 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000679
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
