UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012225
Receipt No. R000014256
Scientific Title The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
Date of disclosure of the study information 2013/11/10
Last modified on 2013/11/01

* 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 The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
Acronym AKBSG13-02
Scientific Title The efficacy and safety of Fluvestrant 500mg treatment in Japanese postmenopausal and hormone receptor positive and HER2 Negative metastatic Breast Cancer
Scientific Title:Acronym AKBSG13-02
Region
Japan

Condition
Condition ER positive postmenopausal advanced breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the contribution of Fulvestrant in patients with hormonal therapy pre threated to overall hormonal treatment sequence by confirming the efficacy of Fulveatrant and Nolvadex
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Clinical Benefit Rate of Fulvestrant CBR=Response Rate+LongSD(NC>=24week)
Key secondary outcomes Changes in QOL
Chenges in BMD
chenges in fat metabolism

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 Fulvesutrant,Tamoxifen
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)Postmenopausal
2)Recurrence/Advance Breast Cancer
3)Histological confirmed invasive breast cancer by biopsy
4)Prior endocrine therapy
5)Measurable lesion
6)Cytological confirmed breast cancer
7)Estrogen receptor(ER)
positive by Immunohistochemistry(IHC=>1%)
confirmed by biopsy before treatment
8)Principal organs(bone marrow, heart, kidneys, etc.)are functionally preserved
9)ECOG performance status(P.S.)0,1or 2
10)Written informed consent
11)Patients projected to live at least for 3M or longer from the trial start
Key exclusion criteria 1)Active double cancer
2)Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer
3)noninfiltrating cancer
4)Inflammatory breast cancer
5)Serious complication
6)Heart disease that requires treatment, such as ischemic heart disease and abnormal cardiac rhythm (Left ventricular hypertrophy due to hypertension, non-severe left ventricle overload, or non-severe right bundle branch block can be included)
7)Brain metastasis
8)Medication of investigational new drug for diseases other than breast cancer or disorder Taking hormone replacement therapy or selective estrogen receptor
9)The case judged inappropriate by physicians

Target sample size 57

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Horiguchi
Organization Gunma university school of medicine
Division name Department of thoracic and visceral Organ surgery
Zip code
Address 3-39-22 Showa-machi, Maebashi City, Gunma Japan
TEL 027-2208245
Email junhorig@showa.gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Higuchi
Organization Gunma university school of medicine
Division name Department of thoracic and visceral Organ surgery
Zip code
Address 3-39-22 Showa-machi, Maebashi City, Gunma Japan
TEL 027-2208245
Homepage URL
Email m11702025@gunma-u.ac.jp

Sponsor
Institute Gunma university
Institute
Department

Funding Source
Organization None
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
2013 Year 11 Month 10 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 Preinitiation
Date of protocol fixation
2013 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 06 Day
Last modified on
2013 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014256

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.