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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010492
Receipt No. R000012268
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
Date of disclosure of the study information 2013/04/14
Last modified on 2018/01/05

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Basic information
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
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Clinical benefit rate
Key secondary outcomes Objective response rate, progression-free survival, adverse events, endocrine-related symptoms

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 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

Research contact person
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

Public contact
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

Sponsor
Institute Study group for metastatic breast cancer
Institute
Department

Funding Source
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

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
2013 Year 04 Month 14 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 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
Other related information Tumor response (RECIST version 1.1)
Adverse events (CTCAE version 4)

Management information
Registered date
2013 Year 04 Month 14 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012268

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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