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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012849
Receipt No. R000015013
Scientific Title Examination of utility of fulvestrant 500mg intended for climacteric junior line relapse breast cancer patient
Date of disclosure of the study information 2014/01/29
Last modified on 2016/02/14

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Basic information
Public title Examination of utility of fulvestrant 500mg intended for climacteric junior line relapse breast cancer patient
Acronym NGFBCS14-01
Scientific Title Examination of utility of fulvestrant 500mg intended for climacteric junior line relapse breast cancer patient
Scientific Title:Acronym NGFBCS14-01
Region
Japan

Condition
Condition ER-positive postmenopausal metastatic/inoperable breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of 500mg Fulvestrant therapy in patients with inoperable or metastatic ER-positibe postmenopausal breast cancer within 2-4 ET regimens.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical Benefit Rate(CBR)
Key secondary outcomes Overall Response Rate(ORR)
Progression Free Survival (PFS)
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Patients who were histologically or cytologically diagnosed as inoperable/metastatic breast cancer.
2. ER-positibe in primary or metastatic lesions.
3.Patient of either of 1 for which endocrinotherapy is needed due to progress
relapse breast cancer as follows) -4).
1)Patient who relapsed within 12 months in supplementary treatment period of after the operation by endocrinotherapy or after supplementary treatment ends after the operation.
2)Patient where it relapses after 12 months or more have passed since supplementary treatment ended by endocrinotherapy after the operation, and progress was admitted for endocrinotherapy period afterwards.
3)Patient where progress was admitted for endocrinotherapy period as the first treatment to progress breast cancer patient.
4)Patient from whom progress was admitted in the 2nd or the third endocrinotherapy to progress/recurrence breast cancer
4. The 17th edition (June, 2012)/of the breast cancer handling rule Target (It is possible to measure it) change to a morbid state by the
RECIST standard (the 1.1th edition) is possessed.
5.Age 45-year-old or more postmenopausal women.
6. Written informed consent
Key exclusion criteria 1. Life threatening including
2.Inflammatory breast cancer
3. Allergy to fulvestrant.
4. Previous therapy by fulvestrant
5. Patients considered ineligible by the attending physician.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Tobinaga
Organization JA Aichi Konan Kosei Hospital
Division name Breast surgery
Zip code
Address 137 Omatsubara Takaya-cho Konan City Aichi Japan
TEL 0587-51-3333
Email j-tobinaga@konan.jaaikosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Tobinaga
Organization JA Aichi Konan Kosei Hospital
Division name Breast surgery
Zip code
Address 137 Omatsubara Takaya-cho Konan City Aichi Japan
TEL 0587-51-3333
Homepage URL
Email j-tobinaga@konan.jaaikosei.or.jp

Sponsor
Institute JA Aichi Konan Kosei Hospital
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 JA愛知厚生連 江南厚生病院      JA Aichi Konan Kosei Hospital

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 29 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 11 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 01 Day
Date trial data considered complete
2018 Year 05 Month 01 Day
Date analysis concluded
2018 Year 06 Month 01 Day

Other
Other related information None

Management information
Registered date
2014 Year 01 Month 14 Day
Last modified on
2016 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015013

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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