UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Title of the study (Brief title)	Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the antitumor activity, as measured by clinical tumor response of 16-week treatment with letrozole as preoperative endocrine therapy in untreated postmenopausal hormone receptor positive patients with primary breast cancer of stage IIA-IIB. Breast-conserving surgery will be conducted when the tumor diameter is within 3 cm and the breast-conserving surgery according to the guideline for the breast-conserving surgery is indicated. When the tumor diameter is over 3 cm in patients other than PD, letrozole treatment will be continued for 8 weeks and antitumor effect will be evaluated in 24 week. Perform of breast-conserving surgery will be reviewed with the tumor diameter of 3 cm as a criterion. Histological effect and safety will also be evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical tumor response rate
Key secondary outcomes	1. Percentage of performing breast- conserving surgery 2.Histological effect in the extensive intraductal component of breast cancer 3.Difference in clinical tumor response effect depending on the expression of HER2 4.Effect for suppressing estradiol concentration in cancer tissues 5.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	Letrozole (2.5 mg Tablet) is internally 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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	1.Diagnosed histologically as having had invasive breast cancer 2.Postmenopausal women 3.Measurable tumor lesion 4.Clinical stage IIA-IIB 5.ER and/or PgR positive defined with immunohistochemical staining 6.Performance status of 0 to 1 7.Adequate organ function 8.Benefit is expected to be obtained from the preoperative endocrine therapy 9. A written informed consent is obtained
Key exclusion criteria	1.Under chemotherapy and hormone therapy(for tumors) 2.Invasive carcinoma of other organs(less than 5 years after the last treatment) 3.With past history of breast cancer 4.Synchronous bilateral breast cancer 5.Under treatment with the drugs that may influence on the conditions of sex hormone
Target sample size	45

Research contact person
Name of lead principal investigator	Hiroshi Sonoo
Organization	Kawasaki Medical School
Division name	Department of Breast and Thyroid Surgery
Address	577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Email	sonoo@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Katsuhiro Tanaka
Organization	Kawasaki Medical School
Division name	Department of Breast and Thyroid Surgery
Address	577 Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email	tanakaka@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	2007 Year 11 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2006 Year 12 Month 13 Day
Anticipated trial start date	2007 Year 07 Month 01 Day
Last follow-up date	2010 Year 07 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	2007 Year 11 Month 08 Day
Last modified on	2018 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001062