UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015698
Receipt number R000018218
Scientific Title Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients
Date of disclosure of the study information 2014/11/17
Last modified on 2018/11/18 10:01:40

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Basic information

Public title

Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients

Acronym

AIR-EE2

Scientific Title

Phase II trial of ethinylestradiol for aromatase inhibitor-resistant postmenopausal advanced/recurrent breast cancer patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiromitsu Jinno

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

35 Shinanomachi Shinjuku, Tokyo, Japan

TEL

03-3353-1211

Email

yokoe@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takamichi Yokoe

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code


Address

35 Shinanomachi Shinjuku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL


Email

yokoe@z2.keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 17 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

2014 Year 11 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018218


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name