UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Title of the study (Brief title)	A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Region	Japan

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

Objectives
Narrative objectives1	To clarify the safety of omitting axillary dissection in patients with breast cancer and one to two postive sentinel nodes.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5year axillary recurrence rate
Key secondary outcomes	1)Overall survival 2)recurrence-free suvival 3)local recurrence-free suvival 4)the rate of upper-limb lymphedema 5)Quality of life 6)comparison of axillary recurrence rate between patients with two or more nodes dissected and only one positive node and those with other situation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	to omit axillary dissection for patients with one to two positve sentinel lymph nodes
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	80 years-old >
Gender	Female
Key inclusion criteria	1) diagnosed as breast cancer by core needle/vacuum assisted biopsy 2)clinical N0 3)planned to undergo lumpectomy and radiation therapy 4)written informed consent
Key exclusion criteria	prior therapy T3,T4 M1
Target sample size	189

Research contact person
Name of lead principal investigator	Takahiro Okamoto
Organization	Tokyo Women's Medical University
Division name	Department of Breast and Endocrine Surgery
Address	Kawadacho 8-1, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	okamoto.takahiro@twmu.ac.jp

Public contact
Name of contact person	Akira Hirano
Organization	Tokyo Women's Medical University, Medical Center East
Division name	Department of Breast Surgery
Address	Nishi-ogu 2-1-10, Arakawa-ku, Tokyo
TEL	03-3810-1111
Homepage URL
Email	ahirasu@dnh.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2016 Year 08 Month 30 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2016 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026489