UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	High-Dose TOREMIFENE for non-steroidal AI failure
Title of the study (Brief title)	HI-TORE Study
Region	Japan

Condition
Condition	Recurrent breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of high-dose tremifene for non-steroidal aromatase inhibitor failure postmenopausal breast cancer patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	.Clinical benefit .Response Rate (CR, PR)
Key secondary outcomes	.TTP(Time to progression) .TTF(Time to treatment failure)

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	high-dose toremifene 120mg/body
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. Case confirmed by pathological diagnosis. 2. Postmenopausal women with breast cancer by mastectomy or breast conserving surgery. 3. Recurrent breast cancer patients who are taking anastorozole or letrozole as an adjuvant therapy. 4. Recurrent breast cancer patients who have finished anastorozole or letrozole as an adjuvant therapy less than 1 year ago. 5. Case with measurable primary lesions. 6. Case with positive ER or PgR. 7. Case with PS 0 or 1. 8. Case with a satisfactory function of a heart liver kidney bone marrow ant to satisfy the next condition. 9. Case stopped anastorozole or letrozole more than 2 weeks ago. 10. Case that last menstration was observed more than 1 year ago. 11. Case that survival more than 3 months is anticipated. 12. Case signedinformed consent of the patients for the registration.
Key exclusion criteria	(1)Contraindication case for toremifene. (2)Case with inflammatory breast cancer or bilateral breast cancer. (3)Case with active other malignancies. (4)Case with life-threatening metastasis. (5)Case with past history of drug allergy or hypersensitivity. (6)Case with past use of anti-estrogen drug. (7)Case judged inappropriate by physicians.
Target sample size	60

Research contact person
Name of lead principal investigator	Shoichiro Ohtani
Organization	Hiroshima City Hospital
Division name	Department of Breast surgery
Address	7-33, Motomachi, Naka-ku, Hiroshima
TEL	082-221-2291
Email

Public contact
Name of contact person	Shoichiro Ohtani
Organization	Hiroshima Breast Cancer Study Group
Division name	Hiroshima Cancer Support
Address	1-20, Honkawa-cho, Naka-ku, Hiroshima
TEL	0825443770
Homepage URL	http://www.ac.auone-net.jp/~hcancer/down.htm
Email	sho_ohtani@hotmail.com

Sponsor
Institute	Hiroshima Breast Cancer Study Group
Institute
Department

Funding Source
Organization	Hiroshima Breat Cancer Study Group
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	Hiroshima Breast Cancer Study Group

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 11 Month 13 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2014 Year 12 Month 01 Day
Date trial data considered complete	2014 Year 12 Month 01 Day
Date analysis concluded	2015 Year 02 Month 01 Day

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

Management information
Registered date	2010 Year 02 Month 13 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003798