UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028774
Receipt No. R000032851
Scientific Title Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
Acronym JBCRG-S01
Scientific Title Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
Scientific Title:Acronym JBCRG-S01
Region
Japan Asia(except Japan)

Condition
Condition Operable breast cancer(stage I-III)
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the average efficacy rate of Abraxane-containing regimen as a neoadjuvant chemotherapy for breast cancer in Japan based on the following two hypotheses.
For anthracycline and taxane containing regimen as a neoadjuvant chemotherapy, the following two hypotheses are set up.
1.Abraxane as taxane may show a high pCR rate in combination with trastuzumab for HER2-positive breast cancer.
2.Abraxane as taxane may be safe and tolerable for most of patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes pCR: pathological complete response
Key secondary outcomes Adverse events(>=G3)
RDI(Relative dose intensity for Abraxane)

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)Clinical trial(s) started after July 2010.
2)Principal investigator(s) in each trial agree with participation in this study.
3)Abraxane-containing regimen was used for neoadjuvant chemotherapy in naive operable breast cancer patients.
4)Registered in UMIN with ethical review.
5)Clinical trials in which more than 10 patients participated.
6)Clinical trials that have already been completed (unpublished data are available).
7)To submit the data, each researcher was authorized by each research ethics committee.
Key exclusion criteria Patients who are unwilling to participate in this study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1.Manabu Futamura 2.Mari Oba 3.Norikazu Masuda
Organization 1. Gifu University Hospital
2. Toho University
3. National Hospital Organization Osaka Medical Center
Division name 1. Dept. of Surgical Oncology 2. Dept. of Medical Statistics Faculty of Medicine 3. Dept. of Surgery, Breast Oncology
Zip code
Address 1) 1-1Yanagito Gifu, Gifu 501-1194, Japan 2) 6-11-1, Omorinishi, Ota-ku, Tokyo, 143-8541, Japan 3) 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan
TEL 058-230-6235
Email mfutamur@gifu-u.ac.jp

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

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

Funding Source
Organization TAIHO Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 岐阜大学医学部附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Backgraund:
1.Classification of sex
2.Age
3.Menopausal Status
4.Performance Status

Stage:
TNM Classification

Histopathological Finding:
1.Histological Type
2.Hormonal Receptor(ER/PgR)
3.HER2(IHC, FISH/DISH)
4.Histological/Nuclear Grade
5.Ki-67 labelling index
6.Clinical Stage

Neoadjuvant Chemotherapy:
1.Chemotherapy regimen(Abraxane is mandatory)
2.Trastuzumab(does, duration)
3.Administered Cycle/dose of chemotherapy
4.Adverse events(>=G3)
5.Clinical outcome due to RECIST

Operation:
1.Pathological stage
2.Histological grade
3.Status of axillary lymph node metastasis
4.Hormonal Receptor(ER/PgR)
5.HER2(IHC, FISH/DISH)
6.Ki67
7.pCR(ypT0ypN0, ypT0/isypN0, ypT0/isypNX)

Management information
Registered date
2017 Year 08 Month 22 Day
Last modified on
2018 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032851

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.