UMIN-CTR Clinical Trial

Basic information
Public title	Axillary evaluation with targeted axillary dissection using ultrasound visible clips after neoadjuvant chemotherapy for patients with node-positive breast cancer
Acronym	Axillary evaluation with targeted axillary dissection
Scientific Title	Axillary evaluation with targeted axillary dissection using ultrasound visible clips after neoadjuvant chemotherapy for patients with node-positive breast cancer
Scientific Title:Acronym	Axillary evaluation with targeted axillary dissection
Region	Japan

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

Objectives
Narrative objectives1	To investigate the feasibility and accuracy of targeted axillary dissection using an ultrasound visible clip for the axillary staging of patients with node-positive breast cancer treated with NAC, with the secondary aim of assessing the US visibility of the clip and localization technique of TAD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	False negative rate of the targeted axillary dissection is assessed
Key secondary outcomes	Ultrasound identification rate and success removal rate of the clipped node using several localization technique such as fluorescence technique, wire localization, dye injection method, or combination of these techniques under US guidance are assessed

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	Maneuver
Interventions/Control_1	After a clip is placed in the biopsy-proven node under US guidance, neoadujuvant chematherapy is performed. At the time of surgery, clipped node is removed followed by sentinel lymph node biopsy.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with clinical T1-3, N1,2, M0 breast cancer undergoing NAC followed by surgery.
Key exclusion criteria	Patients with internal mammary lymph node metastasis, prior axillary surgery, or pregnancy
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Eisuke Middle name Last name Fukuma
Organization	Kameda Medical Center
Division name	Breast Center
Zip code	290-8602
Address	929, Higashi cho, Kamogawa, Chiba
TEL	0470-92-2211
Email	fukuma.eisuke@kameda.jp

Public contact
Name of contact person	1st name Hiroe Middle name Last name Sugane
Organization	Kameda Medical Center
Division name	Breast Center
Zip code	290-8602
Address	929, Higashi cho, Kamogawa, Chiba
TEL	0470-92-2211
Homepage URL
Email	sugane.hiroe@kameda.jp

Sponsor
Institute	Breast Center, Kameda medical center
Institute
Department

Funding Source
Organization	Breast Center, Kameda medical center
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	Kameda Medical Center
Address	929 Higashi cho, Kamogawa, Chiba
Tel	0470-92-2211
Email	clinical_research@kameda.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	亀田総合病院

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 08 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	26
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	Completed
Date of protocol fixation	2016 Year 11 Month 28 Day
Date of IRB	2016 Year 11 Month 28 Day
Anticipated trial start date	2017 Year 01 Month 10 Day
Last follow-up date	2022 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 09 Month 08 Day
Last modified on	2022 Year 09 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055701