UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012067 |
|---|---|
| Receipt number | R000014098 |
| Scientific Title | Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer |
| Date of disclosure of the study information | 2013/10/25 |
| Last modified on | 2019/10/23 10:13:19 |
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Basic information
Public title
Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer
Acronym
Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer
Scientific Title
Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer
Scientific Title:Acronym
Multicenter study to confirm the correlation of clinical benefit rate(CBR) and cancer related factors in the use of Fulvestrant as a second line treatment for postmenopausal advanced and recurrence breast cancer
Region
| Japan |
Condition
Condition
ER positive postmenopausal advanced breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify CBR predictive factors of Fulvestrant by confirming the correlation of:
- CBR (clinical benefit rate) of Fulvestrant as a second line endocrine therapy in advanced or recurrence breast cancer patients with no prior endocrine therapy, and
- cancer related factors obtained from gene analysis of biopsy tissue (breast cancer cells) taken from subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify biological factors and clinical pathological factors as CBR predictive factor of Fulvestrant
Key secondary outcomes
Clinical Benefit Rate of Fulvestrant
CBR = Response Rate + Long SD
Time To Progression
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 after Non Steroidal Aromatase Inhibitor (Anastrozole or Letrozole) failure
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) Histological confirmed invasive breast cancer by biopsy
2) Postmenopausal
patients who fulfill at least one of the following as a condition of menopause
60 years of age or older
45 years of age or older with amenorrhea more than two years
Provided that no hysterectomy
bilateral oophorectomy
3) Estorogen receptor (ER) positive by Immunohistochemistrv(IHC; => 1%) confirmed by biopsy before treatment.
4) HER2 negative (IHC: 1+ or 0, or FISH: negative) by biopsy before treatment
5) Measurable lesion
6) Principal organs (bone marrow, heart, 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 <= 1.25 x Upper limit of facility reference
Serum creatinine <= 1.25 x Upper limit of facility reference
clinically normal range by cardiac function electrocardiogram
Key exclusion criteria
1) Prior chemotherapy(2 regimen or more) or endocrine therapy
2) Taking radiation therapy for target lesion
3) Taking hormone replacement therapy or selective estrogen receptor
4) History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease)
5) Active double cancer
6) Inflammatory breast cancer
7) Bilateral breast cancer
8) History of allergic reactions for drugs and contract medium to be used in this study
9) Medication of investigational new drug for diseases other than breast cancer
10) Patients who are impossible to be enrolled due to psychological diseases or disorder
11) The case judged inappropriate by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Hayashi |
Organization
Tohoku university school of medicine
Division name
Laboratory of Molecular and Functional Dynamics
Zip code
Address
1-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi, Japan
TEL
022-717-7913
shin@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Ishida |
Organization
Tohoku university
Division name
Breast and endocrine surgery
Zip code
Address
1-1, Seiryo-cho, Aoba-ku, Sendai City, Miyagi, Japan
TEL
022-717-7214
Homepage URL
takanori@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university school of medicine
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
東北公済病院（宮城県）、東北労災病院（宮城県）、独立行政法人国立病院機構 仙台医療センター（宮城県）、仙台市立病院（宮城県）、宮城県立がんセンター（宮城県）、大崎市民病院（宮城県）、石巻赤十字病院（宮城県）、仙台オープン病院（宮城県）、ＮＴＴ東日本東北病院（宮城県）、仙台赤十字病院（宮城県）、日本海総合病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 25 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | 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 | 18 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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