UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Title of the study (Brief title)	Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)
Region	Japan

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

Objectives
Narrative objectives1	Endocrine-sensitive postmenopausal breast cancer patients (60 years of age and over) received preoperative exemestane therapy, and time to progression was assessed as the primary endpoint, and maximum response time, tumor regression rate, pathologic antitumor effect, cell proliferation capacity, TTF, proportion who were able to avoid surgery during the 3 years after the start of treatment, adverse events, and bone mineral density as secondary endpoints.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time To Progression
Key secondary outcomes	1.Maximum efficacy period 2.Rate of tumor reduction 3.Relationship between pathological response rate and capacity of cell proliferation, activity of aromatase and functional analysis of estrogen receptor of breast cancer cells 4.Time To Treatment Failure 5.Adverse events 6.Changes in bone mineral density

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	Exemestane (25 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	60 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Patients diagnosed histologically as having had invasive ductal carcinoma. 2.Patients 60 years or more, at least one of the following features; A.One year have passed since the final menstruation B.Past history of surgical bilateral ovariectomy (including radiotherapy) C.Past history of hysterectomy and the serum levels of FSH, LH, and E2 are postmenopausal levels 3.StageIIA-IIIB 4.ER-positive and HER2-negative defined with immunohistochemical staining 5.PS(WHO):0-1 6.Patients who satisfy the reference levels of blood cell count and biochemical examination at the institutions 7.Benefit is expected to be obtained from the initial systemic treatment 8.A written consent is obtained
Key exclusion criteria	1.Patients under chemotherapy and hormone therapy (for tumors) 2.Patients under treatment with the drugs (including HRT) that may influence on the conditions of sex hormone 3.Patients with a past history of breast cancer or with double cancer
Target sample size	23

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

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Executive office(c/o: Shin-toshin Ladies' Clinic)
Address	3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@nyc.odn.ne.jp

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	2007 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 06 Month 04 Day
Anticipated trial start date	2007 Year 08 Month 01 Day
Last follow-up date	2012 Year 08 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2007 Year 08 Month 17 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=R000000961