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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003900
Receipt No. R000004692
Scientific Title Phase II trial of axilla treatment after primary chemotherapy for breast cancer patients with sentinel lymph node metastases
Date of disclosure of the study information 2010/07/14
Last modified on 2012/07/04

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Basic information
Public title Phase II trial of axilla treatment after primary chemotherapy for breast cancer patients with sentinel lymph node metastases
Acronym Axilla treatment after chemotherapy for sentinel node-positive breast cancer patients
Scientific Title Phase II trial of axilla treatment after primary chemotherapy for breast cancer patients with sentinel lymph node metastases
Scientific Title:Acronym Axilla treatment after chemotherapy for sentinel node-positive breast cancer patients
Region
Japan

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

Objectives
Narrative objectives1 To clarify axilla management after neoadjuvant chemotherapy for breast cancer patients with pN1mi(sn) or pN1(sn)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Positive rate of axillary nodes after primary chemtoherapy
Key secondary outcomes 5-year overall survival rate of breast cancer patients after primary chemotherapy

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 Maneuver
Interventions/Control_1 Sentinel node biopsy, primary chemotherapy, breast surgery with axillary lymph node dissection
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
70 years-old >=
Gender Female
Key inclusion criteria T1-3N0M0
Invasive cancer
pN1mi(sn) or pN1(sn)
Key exclusion criteria Breast cancer patient during pregnancy
Bilateral breast cancer
Primary endocrine therapy
Target sample size 98

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Imoto
Organization School of Medicine, Kyorin University
Division name Department of Breast Surgery
Zip code
Address 6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Yana
Organization Japanese Society for Sentinel Node Navigation Surgery
Division name Office
Zip code
Address Department of Surgery, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku,Tokyo
TEL 03-3353-6440
Homepage URL
Email yanas@sc.itc.keio.ac.jp

Sponsor
Institute Japanese Society for Sentinel Node Navigation Surgery
Institute
Department

Funding Source
Organization Japanese Society for Sentinel Node Navigation Surgery
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 旭川医科大学病院(北海道)、岩手医科大学病院(岩手)、山形県立中央病院(山形)、山形大学病院(山形)、福島県立医科大学病院(福島)、佐野厚生総合病院 (栃木)、埼玉社会保険病院(埼玉)、埼玉県立がんセンター(埼玉)、国立がん研究センター東病院(千葉)、千葉大学病院(千葉)、慶應義塾大学病院(東京)、国立がん研究センター中央病院(東京)、虎の門病院(東京)、日野市立病院(東京)、杏林大学病院(東京)、神奈川県立がんセンター(神奈川)、愛知医科大学 病院(愛知)、松波総合病院(岐阜)、国立病院機構大阪医療センター(大阪)、
関西医科大学附属枚方病院(大阪)、大阪市立大学病院(大阪)、長崎大学病院(長崎)、鹿児島大学病院(鹿児島)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 14 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 Terminated
Date of protocol fixation
2010 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 10 Day
Last modified on
2012 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004692

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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