UMIN-CTR Clinical Trial

Basic information
Public title	Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Acronym	Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Scientific Title	Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Scientific Title:Acronym	Study on standardizing the omission of axillary dissection for breast cancer with disappeared lymph node metastases after preoperative chemotherapy
Region	Japan

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

Objectives
Narrative objectives1	We examine whether omitting axillary dissection increases the rate of local recurrence. The subject is a case in which lymph node metastasis disappears after preoperative chemotherapy and sentinel lymph node is negative.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Local recurrence rate
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1.Histologically diagnosed breast cancer (regardless of histological type) 2.Diagnosed as positive for axillary lymph node metastasis 3.At the time of diagnosis, hormone receptor is negative 4.Clips can be inserted into lymph nodes that are positive for metastasis 5.Within 3 lymph nodes suspected of metastasis 6.Preoperative chemotherapy is planned 7.Patients who have given written consent to participate in this study
Key exclusion criteria	1.Patients who cannot use the clips used in the research 2.Patients after breast implant insertion 3.Inflammatory breast cancer 4.Relapsed breast cancer 5.Pregnant patients 6.Patients who are infected or suspected of having an infectious disease 7.Patients who are judged to be ineligible at the discretion of the investigator 8.Sentinel lymph node cannot be identified 9.Clip lymph node cannot be identified 10.When the number of removed lymph nodes is less than the number determined to be metastatic lymph nodes before the start of treatment
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Nakamura
Organization	Showa University Hospital
Division name	Department of Breast Surgical Oncology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL	03-3784-8000
Email	showa-bc@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Sayuka Middle name Last name Nakayama
Organization	Showa University Hospital
Division name	Department of Breast Surgical Oncology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL	03-3784-8000
Homepage URL
Email	osau0310@gmail.com

Sponsor
Institute	Department of Breast Surgical Oncology, Showa University Hospital
Institute
Department

Funding Source
Organization	Showa University
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	Showa University
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
Tel	03-3784-8000
Email	osau0310@gmail.com

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	2022 Year 05 Month 20 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	Open public recruiting
Date of protocol fixation	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 07 Month 11 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2029 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	After inserting a clip into the metastatic lymph node, preoperative chemotherapy and surgery are performed as scheduled. After surgery, a breast ultrasound and a medical examination are performed at least once a year.

Management information
Registered date	2022 Year 05 Month 19 Day
Last modified on	2022 Year 05 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054497

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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