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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015168
Receipt No. R000017287
Scientific Title Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
Date of disclosure of the study information 2014/09/16
Last modified on 2021/06/21

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Basic information
Public title Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
Acronym JBCRG-C06
Scientific Title Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
Scientific Title:Acronym JBCRG-C06
Region
Japan

Condition
Condition Patients with postmenopausal ER-positive advanced recurrent breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to retrospectively evaluate effects of subject's clinical background and prior therapies on the treatment time with Fulvestrant(TTF), in patients with postmenopousal ER-positive advanced recurrent breast cancer receiving Fulvestrant in clinical setting in Japan. Also this study is to explore the impact on prognosis for advanced recurrent breast cancer receiving Fulvestrant as a secondary analysis.
In the explanatory analysis study, JBCRG-C06-A1 (MPA analysis), using the data accumulated in C06, the TTF (treatment success period) of MPA is clarified as real world data, and factors affecting TTF in patients using MPA in the third and subsequent treatments are investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Effects of clinical background and prior therapies on the treatment time with Fulvestrant (TTF)
Key secondary outcomes Secondary analysis
1.Effects of clinical background and prior therapies on overall survival (OS) after start of Fulvestrant
2.Descriptive statistics of treatment
3.Summary of therapies administered to subjects with long survival
In the explanatory analysis study JBCRG-C06-A1 (MPA analysis), the treatment success period of MPA by treatment line (TTF), the number of endocrine therapy treatment lines for progression recurrence of MPA, and patient factors for TTF of MPA are evaluated.

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) Patients with postmenopausal ER-positive advanced recurrent breast cancer after prior hormone therapy
2) Register the patients that start to use Fulvestrant between November, 2011 (after release of Fulvestrant) and December 31, 2014 in a real clinical treatment
Key exclusion criteria 1)Patients not agree with this study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name C061)Hidetoshi 2)Shinji C06-A11)Hidetoshi 2)Yutaka
Middle name
Last name JBCRG-C06 1)Kawaguchi 2)Ohno JBCRG-C06-A1 1)Kawaguchi 2)Yamamoto
Organization JBCRG-C06 1) Matsuyama Red Cross Hospital
2) The Cancer Institute Hospital Of JFCR
JBCRG-C06-A1 1) Matsuyama Red Cross Hospital 2) Kumamoto University, Graduate School of Medical Sciences
Division name JBCRG-C06 1) Department of breast surgery 2) Breast Oncology Center JBCRG-C06-A1 1) Department of breast surgery 2) Department of breast and endocrine surgery
Zip code 790-8524
Address 1) 1 Bunkyo-cho , Matsuyama-shi, Ehime Japan
TEL 089-924-1111
Email hkawaguchi@matsuyama.jrc.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, Japan
TEL 03-6264-8873
Homepage URL https://jbcrg.jp/
Email office@jbcrg.jp

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

Funding Source
Organization AstraZeneca K.K.(JBCRG-C06)
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Department of Breast and Endocrine Surgery, Graduate School of Life Sciences, Kumamoto University (JBCRG-C06,JBCRG-C06-A1)

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email N/A

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 松山赤十字病院(愛媛県)、国立病院機構 九州がんセンター(福岡県)、弘前市立病院(青森県)、新潟県立がんセンター新潟病院(新潟県)、久留米総合病院(福岡県)、広島市民病院(広島県)、愛知県がんセンター中央病院(愛知県)、相良病院(鹿児島県)、北海道大学病院(北海道)、群馬県立がんセンター(群馬県)、昭和大学病院(東京都)、四国がんセンター(愛媛県)、北九州市立医療センター(福岡県)、がん研究会有明病院(東京都)、虎の門病院(東京都)、熊本大学医学部附属病院(熊本県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 16 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 710
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Additional publication is awaiting.
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
2014 Year 07 Month 30 Day
Date of IRB
2013 Year 08 Month 08 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded

Other
Other related information This study is a retrospective observational study to investigate clinical experience of Fulvestrant. The study does not involve study-specific intervention such as treatments or tests because it is designed as an observational study. Instead, data obtained from daily practice is surveyed. Treatment method is selected for each subject by the attending physician and the subject herself.

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2021 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017287

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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