UMIN-CTR Clinical Trial

Basic information
Public title	Study on the omission of axillary lymph node dissection for breast cancer patients with metastases positive sentinel lymph node
Acronym	Study on the omission of axillary lymph node dissection for sentinel node-positive breast cancer patients
Scientific Title	Study on the omission of axillary lymph node dissection for breast cancer patients with metastases positive sentinel lymph node
Scientific Title:Acronym	Study on the omission of axillary lymph node dissection 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 validate the safety of no axillary lymph node dissection in sentinel node-positive breast cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence rate of axillary lymph node
Key secondary outcomes	5-year overall survival rate 5-year recurrent free survival rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed breast cancer patients without distant metastasis 2) T1-2, NO 3) Patients who received sufficient explanation, understood it and gave written consent based on their free will, before participating in this study
Key exclusion criteria	1) Patients who undergo breast surgery for ipsilateral breast tumor recurrence 2) Patients who undergo axillary lymph node dissection or sampling after sentinel lymph node biopsy 3) Patients who undergo neoadjuvant therapy 4)Patients who were judged inappropriate by the principal investigator
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazuyoshi Middle name Last name Motomura
Organization	Osaka General Medical Center
Division name	Department of Breast Surgery
Zip code	558-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Email	kenkyusien@gh.opho.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Motomura
Organization	Osaka General Medical Center
Division name	Department of Breast Surgery
Zip code	558-8558
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL	06-6692-1201
Homepage URL
Email	kenkyusien@gh.opho.jp

Sponsor
Institute	Osaka General Medical Center
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)

IRB Contact (For public release)
Organization	Osaka General Medical Center
Address	3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
Tel	06-6692-1201
Email	kenkyusien@gh.opho.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	大阪府立急性期・総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 15 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	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 15 Day
Date of IRB	2017 Year 06 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study No axillary lymph node dissection and recurrence rate

Management information
Registered date	2015 Year 07 Month 15 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021199