UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000014098