UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012849 |
|---|---|
| Receipt number | 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 22:33:38 |
* 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
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
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
j-tobinaga@konan.jaaikosei.or.jp
Sponsor or person
Institute
JA Aichi Konan Kosei Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
