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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002737
Receipt No. 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 2018/08/23

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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
Middle name
Last name Hiroyasu Yamashiro
Organization JBCRG(Japan Breast Cancer Research Group)
Division name Department of Surgery and Oncology
Zip code
Address 54 Kawara-cho Shogoin,
TEL 075-751-3660
Email yamashiro.bcs@gmail.com

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

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

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
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
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
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
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002520

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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