UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003900 |
|---|---|
| Receipt number | 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 14:23:03 |
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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
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
yanas@sc.itc.keio.ac.jp
Sponsor or person
Institute
Japanese Society for Sentinel Node Navigation Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004692
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