UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for serum estrogen concentration during aromatase inhibitor treatment
Title of the study (Brief title)	Serum E2 study
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study was designed to investigate intra-patient or inter-patients variability of serum E2 level during aromatase inhibitor treatments.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum E2 level on aromatase inhibitor
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Breast cancer patients treated with AI as adjuvant therapy
Key exclusion criteria	Concurrent endocrine treatment other than AI
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Ishiguro
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Target Therapy Oncology
Address	54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL	075-751-4950
Email	hkkishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Moe Tsuda
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Breast Surgery
Address	54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL	075-751-3660
Homepage URL
Email	moe1985@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization	Japan's Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	G-629
Org. issuing International ID_1	Kyoto University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 07 Day
Anticipated trial start date	2014 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Measure serum E2 level after initiation of AI for at least 4 weeks. Interval between the measure meant is at least 2 months.

Management information
Registered date	2014 Year 02 Month 25 Day
Last modified on	2016 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015472