UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Acronym	A pilot study for breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Scientific Title	A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Scientific Title:Acronym	A pilot study for breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is the observation of the early change of estrogen receptor in patients with advanced and/or recurrent breast cancer after endocrine therapy with or without palbociclib using 16alpha-18F-fluoro-17beta-estradiol (18F-FES) PET.
Basic objectives2	Others
Basic objectives -Others	It is interesting to observe the early change of estrogen receptor in the patients with advanced and/or recurrent breast cancer by endocrine therapy with or without CDK4/6 inhibitor ( palbociclib or abemaciclib ). This is a pilot study to investigate the change of estrogen receptor 2-4 month after initiation of the therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the change rate of FDG-SUVmax
Key secondary outcomes

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	FES-PET/CT: before and 2-4 months after the beginning of therapy
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	20 years-old <
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. patients with advanced and/or recurrent breast cancer with ER positive and HER2 negative 2. patients more than 20 years-old at the time of the informed consent. 3. patients planned to be treated with endocrine therapy ( Aromatase inhibitors, Tamoxifen, Fulvestrant, Toremifene ) and/or CDK4/6 inhibitors ( Palbociclib or Abemaciclib ) 4. patients signed the documentation of the informed consent
Key exclusion criteria	1. patients with the serum fasting glucose level is more than 150mg/dL at the day of entry 2. patients who entered to the other clinical trials 28 days before the day of entry
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ichiei Middle name Last name Kuji
Organization	Saitama Medical University International Medical Center
Division name	Department of Nuclear Medicine
Zip code	350-1298
Address	Yamane 1397-1, Hidaka, Saitama
TEL	042-984-4147
Email	kuji@saitama-med.ac.jp

Public contact
Name of contact person	1st name Ichiei Middle name Last name Kuji
Organization	Saitama Medical University International Medical Center
Division name	Department of Nuclear Medicine
Zip code	350-1298
Address	Yamane 1397-1, Hidaka, Saitama
TEL	042-984-4147
Homepage URL
Email	kuji@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Nuclear Medicine, Saitama Medical University International Medical Center
Name of secondary funder(s)	Department of Nuclear Medicine, Saitama Medical University International Medical Center

IRB Contact (For public release)
Organization	Saitama Medical University International Medical Center, Clinical trial IRB
Address	Yamane 1397-1, Hidaka, Saitama
Tel	042-984-4523
Email	chikens@saitama-med.ac.jp

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	埼玉医科大学国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2019 Year 08 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	Enrolling by invitation
Date of protocol fixation	2019 Year 07 Month 03 Day
Date of IRB	2019 Year 07 Month 03 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2021 Year 09 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	2019 Year 07 Month 10 Day
Last modified on	2020 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042149

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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