UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients
Title of the study (Brief title)	AIR-EE2
Region	Japan

Condition
Condition	aromatase inhibitor-resistant advanced/recurrent breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients. Primary endpoint is the response rate. Secondary endpoint is the clinical benefit rate, adverse drug reaction and progression-free survival.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response Rate; RR
Key secondary outcomes	Clinical Benefit Rate; CBR Adverse Drug Reaction; ADR Progression-Free Survival; PFS

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ethinylestradiol 3mg will be given orally everyday for 28 days. Three cycle of ethinylestradiol will be given.
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	80 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically confirmed breast cancer 2. Postmenopausal women with ER positive or PgR positive breast cancer 3. Measurable primary/metastatic lesion 4. Inoperable or metastatic breast cancer 5. Performance status 0, 1 or 2 6. Aromatase inhibitor-resistant 7. A case without severe complications and also meets the requirements below 1) WBC; more than 3,500/mm3, less than 10,000/mm3, Plt; more than 100,000/mm3, Hb; more than 10g/dl 2) T-Bil.; less than 1mg/dl, GOT; less than 60 IU/L, GPT; less than 60 IU/L 8. With written informed consent
Key exclusion criteria	1. Inflammatory breast cancer 2. Any malignant neoplasms 3. Severe cardiac disease(e.g. myocardial infarction, valvular disease, heart failure) 4. Liver cirrhosis 5. Thrombosis 6. Judged inappropriate by physicians
Target sample size	40

Research contact person
Name of lead principal investigator	Hiromitsu Jinno
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35 Shinanomachi Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Email	yokoe@z2.keio.jp

Public contact
Name of contact person	Takamichi Yokoe
Organization	Keio University School of Medicine
Division name	Department of Surgery
Address	35 Shinanomachi Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	yokoe@z2.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
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	NO
Study ID_1
Org. issuing International ID_1
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 11 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 13 Day
Anticipated trial start date	2014 Year 12 Month 01 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

Management information
Registered date	2014 Year 11 Month 15 Day
Last modified on	2018 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018218