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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035291
Receipt No. R000040204
Scientific Title Twenty-Four Weeks of Neoadjuvant Exemestane for Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (SBCCSG 23)
Date of disclosure of the study information 2018/12/19
Last modified on 2018/12/17

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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
Middle name
Last name Hiroshi Matsumoto
Organization Saitama Cancer Center
Division name Division of breast surgery
Zip code
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
Middle name
Last name Jun Ninomiya
Organization Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name executive office(Ninomiya Hospital)
Zip code
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 Clinical Study 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
Address
Tel
Email

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
2018 Year 12 Month 17 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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