UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012153 |
|---|---|
| Receipt number | R000014163 |
| Scientific Title | Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2021/05/22 00:22:57 |
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Basic information
Public title
Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Acronym
Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Scientific Title
Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Scientific Title:Acronym
Study to confirm the clinical benefit rate(CBR) in the use of Fulvestrant for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Region
| Japan |
Condition
Condition
ER positive postmenopausal advanced / recurrence breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical benefit rate(CBR) in the use of Fulvestrant after prior hormonal therapy for estrogen receptor positive, HER2 negative Japanese postmenopausal advanced and recurrence breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Benefit Rate of Fulvestrant
CBR = Response Rate + Long SD (SD>=24week)
Key secondary outcomes
Bone Mineral Density(BMD) before/after treatment of Fulvestrant
Bone metabolism maker before/after treatment of Fulvestrant
Change of QOL before/after treatment of Fulvestrant
Adverse Event Rate
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
Fulvestrant
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 breast cancer patient after progression of prior hormonal therapy
patients who fulfill at least one of the following as a condition of menopause
55 years of age or older
45 years of age or older with amenorrhea more than two years
Provided that no hysterectomy
bilateral oophorectomy
2)Estorogen receptor(ER) positive by Immunohistochemistry(IHC => 1%)
3)HER2 negative (IHC 1+ or 0, or FISH negative)
4)Measurable lesion
5)Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved
White blood cell count => 3,000/mm3 or Neutrophil count => 1,500/mm3
Platelet count => 100,000/mm3,
Hemoglobin => 9.0 g/dL
AST, ALT <= 1.5 x Upper limit of facility reference
Total bilirubin <= 1.25 x Upper limit of facility reference
ALP <= 1.5 x Upper limit of facility reference
Serum creatinine <= 1.25 x Upper limit of facility reference
clinically normal range by cardiac function electrocardiogram
6)ECOG performance status (P.S.) 0, 1 or 2
7)Written informed consent
Key exclusion criteria
1)Taking hormone replacement therapy or selective estrogen receptor
2)History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease)
3)Active double cancer
4)Inflammatory breast cancer
5)Bilateral breast cancer
6)History of allergic reactions for drugs and contract medium to be used in this study
7)Medication of investigational new drug for diseases other than breast cancer
8)Patients who are impossible to be enrolled due to psychological diseases or disorder
9)The case judged inappropriate by physicians
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Asaishi |
Organization
Sapporo-Kotoni Breast Clinic
Division name
Breast surgery
Zip code
Address
2-5-15, Kotoni 2jo, Nishi-ku, Sapporo City, Hokkaido, Japan
TEL
011-622-2221
k-breast@cream.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideji Masuoka |
Organization
Sapporo-Kotoni Breast Clinic
Division name
Breast surgery
Zip code
Address
2-5-15, Kotoni 2jo, Nishi-ku, Sapporo City, Hokkaido, Japan
TEL
011-622-2221
Homepage URL
hmbreast@vmail.plala.or.jp
Sponsor or person
Institute
Sapporo-Kotoni Breast Clinic
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
札幌医科大学病院（北海道）、東札幌病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014163
