UMIN-CTR Clinical Trial

Public title

Observational study for evaluation of effecacy and safety of ethinylestradiol therapy for postmenopausal hormone receptor-positive metastatic breast cancer patients heavily pre-treated with endocrine treatment

Acronym

EE2 Observational Study

Scientific Title

Observational study for evaluation of effecacy and safety of ethinylestradiol therapy for postmenopausal hormone receptor-positive metastatic breast cancer patients heavily pre-treated with endocrine treatment

Scientific Title:Acronym

EE2 Observational Study

Region

Japan

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is the evaluation of efficacy and safety for ethinylestradiol therapy in postmenopausal estrogen receptor-positive metastatic breast cancer patients heavily pre-treated with endocrine agents.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Clinical benefit rate

Key secondary outcomes

Objective response rate, progression-free survival, adverse events, endocrine-related symptoms

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1. The case from which informed consent is obtained in written form
2. Primary lesion was histologically diagnosed by biopsy and/or cytology
3. Postmenopausal patient
4. Heavily pre-treated with several endocrine treatment
a. Heavily pre-treated with several aromatase inhibitors in adjuvant and metastatic setting
b. Heavily pre-treated with several aromatase inhibitors and anti-estrogens in adjuvant and metastatic setting
c. whether or not used chemotherapy during prior treatemt in above case a and b
5. Not used chemotherapy before entry this observational study after the latest endocrine therapy
6. The case which has meaurable lesion or osteolytic/mixed bone metastasis
7. Estrogen receptor-positive breast cancer
8. The case from which the survival for six months or more is expected
9. Performance status is 0 or 1. If the patients have bone metastasis, PS 2 are acceptable
10. The case with which the organs function is held enough and the case by which the following conditions are fulfilled
a. Hemogrobine: 8 g/dl or more
b. AST/ALT: 2.5 or less times of the normal value maximum in participating institution
c. BUN: 25 mg/dl or less
d. serum creatinin: 1.5mg/dl or less

Key exclusion criteria

1. History of deep vain thrombosis, myocardial infarction and brain infarction
2. Active double cancer, history of endometrial cancer and History of other cancer within 5 years (exclued in-situ cervical cancer, basal cell carcinoma and squamous cell carcinoma of the skin)
3. HER2-positive breast cancer
4. Bilateral breast cancer
5. inflamatory breast cancer
6. History of sever drug hypersensitivity
7. pregnant or nursing female
8. life-threatening metastatic breast cancer
9. The case which the family doctor judged to be unsuitable for the object of the study

Target sample size

65

Name of lead principal investigator

1st name
Middle name
Last name	Hirotaka Iwase

Organization

Kumamoto University, Graduate School of Medical Science

Division name

Department of Breast and Endocrine Surgery

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

096-373-5521

Email

Name of contact person

1st name
Middle name
Last name	Yutaka Yamamoto

Organization

Kumamoto University Hospital

Division name

Department of Molecular-Targeting Therapy for Breast Cancer

Zip code

Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

096-373-5521

Homepage URL

Email

ys-yama@triton.ocn.ne.jp

Institute

Study group for metastatic breast cancer

Institute

Department

Personal name

Organization

Kumamoto University, Graduate School of Medical Science, Department of Breast and Endocrine Surgery

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

11

Month

12

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

13

Day

Last follow-up date

2015

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Tumor response (RECIST version 1.1)
Adverse events (CTCAE version 4)

Registered date

2013

Year

04

Month

14

Day

Last modified on

2018

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012268