UMIN-CTR Clinical Trial

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
Email	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
Email	hmbreast@vmail.plala.or.jp

Sponsor
Institute	Sapporo-Kotoni Breast Clinic
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014163