UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Title of the study (Brief title)	Assessment of the Efficacy of High-Dose Toremifene 120mg Therapy for Anastorozole-resistant Postmenopausal Breast Cancer (SBCCSG-11)
Region	Japan

Condition
Condition	Postmenopausal breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Postmenopausal breast cancer patients who were relapsed during or within one year after completion of anastorozole treatment received high-dose toremifene,and efficacy and predictive factors were assessed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	clinical benefit
Key secondary outcomes	1. clinical responce rate 2. progression free survival(PFS) 3. time to progression(TTP) 4. adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Toremifene (120mg) is orally administered once a day everyday.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. A written consent is obtained 2. Patients diagnosed histologically as having had breast cancer at primary lesion 3. Patients relapsed during or after winthin one year completion of anastrozole treatment 4. PS(ECOG):0-2 5. Patients having measurable lesion or assessable bone lesion 6. 7. Patients with expected lifetime for more than 3 months 8. Patients with bone metastasis without radiotherapy
Key exclusion criteria	1. Patients under anti-estrogen hormone therapy 2. Patients under hormone therapy except for anastrozole 3. Patients diagnosed as inflammatory breast cancer 4. Patients with a history of deep venous thrombosis 5. Patients with serious complications A. Patients with ischemic heart disease or cardiac arrhythmia that need treatment(left ventricular hypertrophy or mild left ventricular load induced by hypertension,or mild right bundle-branch block is eligible) B. Patients with a history of myocardial infarction within 6 months onset C. Patietns with uncontrollable diabetes 6. Patients with brain metastasis 7. Patients taking raloxifen (belonging to SERM) for treatment of osteoporosis 8. Doctor's decision for exclusion
Target sample size	40

Research contact person
Name of lead principal investigator	Toshio Tabei
Organization	Saitama Cancer Center
Division name	Breast Oncology
Address	818 Komuro Ina Kitaadati, Saitama 362-0806
TEL	048-722-1111
Email

Public contact
Name of contact person	Toshihiro Kai
Organization	Shintoshin Ladies' Mammoclinic
Division name	Saitama Breast Cancer Clinical Study Group Executive office
Address	3F,Capital Bldg. 4-261-1,Kishiki-cho,Omiya-ku,Saitama-city ,Saitama 330-0843
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization	none
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	2008 Year 01 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2007 Year 11 Month 30 Day
Anticipated trial start date	2008 Year 01 Month 01 Day
Last follow-up date	2013 Year 01 Month 01 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

Management information
Registered date	2008 Year 01 Month 06 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001165