UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002737 |
|---|---|
| Receipt number | R000002520 |
| Scientific Title | Cohort study evaluating (neo) adjuvant trastuzumab for HER2 positive breast cancer |
| Date of disclosure of the study information | 2009/11/11 |
| Last modified on | 2019/11/21 17:13:20 |
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Basic information
Public title
Cohort study evaluating (neo) adjuvant trastuzumab for HER2 positive breast cancer
Acronym
JBCRG-C01
Scientific Title
Cohort study evaluating (neo) adjuvant trastuzumab for HER2 positive breast cancer
Scientific Title:Acronym
JBCRG-C01
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate efficacy of trastuzumab as an adjuvant therapy in primary breast cancer patients who overexpress HER2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Disease-free survival; DFS
Key secondary outcomes
Overall Survival; OS, Safety
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients who meet ALL the following criteria are eligible:
(1)Received, receiving or scheduled to receive trastuzumab as a (neo) adjuvant therapy for operable breast cancer
(2)Received or receiving trastuzumab after January 2006
(3)Histological confirmed invasive breast cancer by biopsy
(4)Stage I to IIIC
(5)Age <=20 years
(6)Signed written informed consent
Key exclusion criteria
not applicable
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Yamashiro |
Organization
Graduated school of medicine, Kyoto university
Division name
Department of Surgery and Oncology
Zip code
606-8507
Address
54 Kawara-cho Shogoin,
TEL
075-751-3660
yamashiro.bcs@gmail.com
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
Japan Breast Cancer Research Group (JBCRG)
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 11 | 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
2024 cases were enrolled. Three-year overall survival rate was 98.9% and 98.3% in the preoperative therapy group, 99.2% in the postoperative therapy group. Three-year relapse-free survival rate was 94.2%, 94.8%, 93.1%, respectively. In multivariate analysis, age and lymph node metastasis were related to relapse - free survival and only age was related to overall survival rate. Adverse events related to Trastuzumab were found in 356 cases (18.8%). Grade 3/4 adverse events were found in 14 cases (0.6%). Cardiotoxicity was found in 11 cases.
Int J Clin Oncol. 2015 Aug;20(4):709-22. doi: 10.1007/s10147-015-0785-8. Epub 2015 Feb 10.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Investigate efficacy of trastuzumab as an adjuvant therapy in primary breast cancer patients who overexpress HER2.
Management information
Registered date
| 2009 | Year | 11 | Month | 10 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002520
| Research Plan | |
|---|---|
| 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 |
