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Recruitment status Terminated
Unique ID issued by UMIN UMIN000012067
Receipt No. 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

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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
Email 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
Email takanori@med.tohoku.ac.jp

Sponsor
Institute Tohoku university school of medicine
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014098

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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