UMIN-CTR Clinical Trial

Basic information
Public title	Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Acronym	Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Scientific Title	Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Scientific Title:Acronym	Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the changes of indication for adjuvant chemotherapy in patients who underwent neoadjuvant endocrine therapy (NAE) and to evaluate the role of NAE for postmenopausal women with ER-positive breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	To investigate the changes of primary indication for adjuvant chemotherapy in patients who underwent neoadjuvant exemestane
Key secondary outcomes	1.objective responce rate 2.tumor size 3.method of surgery 4.rate of positive surgical margin 5.PEPI score 6.pathological response 7.PgR 8.DFS 9.OS 10.safety

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	24 weeks of neoadjuvant exemestane 25mg/day
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	postmenopausal ER positive and HER2 nagative, cStage 2A,2B,3A breast cancer patients
Key exclusion criteria	patients already treated for breast cancer patients with a past history of breast cancer or with double cancer patients who should be treated by any other therapy
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Matsumoto
Organization	Saitama Cancer Center
Division name	Division of breast surgery
Zip code	362-0806
Address	780 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan
TEL	048-722-1111
Email	hiromatsu@cancer-c.pref.saitama.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Ninomiya
Organization	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name	executive office(Ninomiya Hospital)
Zip code	340-0056
Address	2-22-23 Shinsakae, Souka city, Saitama 330-0843, Japan
TEL	048-941-2223
Homepage URL	http://www.sbccsg.org/
Email	jninomiya@grape.plala.or.jp

Sponsor
Institute	Saitama Breast Cancer Care Support Group(SBCCSG)
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama cancer center Institutional review board
Address	780 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806, Japan
Tel	048-722-1111
Email	sccctmo01@cancer-c.pref.saitama.jp

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	2018 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2020 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040204