UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hirotaka Iwase
Organization	Kumamoto University, Graduate School of Medical Science
Division name	Department of Breast and Endocrine Surgery
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5521
Email

Public contact
Name of contact person	Yutaka Yamamoto
Organization	Kumamoto University Hospital
Division name	Department of Molecular-Targeting Therapy for Breast Cancer
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 11 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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