UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study on feasibility of sentinel lymph node biopsy for ycN0 patients treated with primary chemotherapy in cT1-3N1M0 breast cancer
Title of the study (Brief title)	SHARE study
Region	Japan

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

Objectives
Narrative objectives1	To validate false negative rate of sentinel node biopsy in ycN0 cases after primary chemotherapy for clinically node-positive breast cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	false negative rate of sentinel node biopsy
Key secondary outcomes

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	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	sentinel 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	75 years-old >=
Gender	Female
Key inclusion criteria	1) Physical function enough to receive chemotherapy. 2) Unilateral T1-3N1M0 breast cancer by image diagnosis. 3) Invasive cancer proven by histological examination. 4) Lymph node metastases proven with aspiration cytology or core needle biopsy. 5) ycN0 breast cancer after primary chemotherapy.
Key exclusion criteria	1) Non-invasive cancer, or T4 and/or M1 breast cancer. 2) Clinical N0 or N2 and more metastases. 3) Women with pregnancy or breast-feeding. 4) Synchronous bilateral breast cancer 5) Cases with other invasive disease during treatment.
Target sample size	240

Research contact person
Name of lead principal investigator	SHIGERU IMOTO
Organization	Kyorin University Hospital
Division name	Department of Breast Surgery
Address	6-20-2 Shinkawa Mitaka-shi Tokyo JAPAN 181-8611
TEL	0422-47-5511
Email	imoto@ks.kyorin-u.ac.jp

Public contact
Name of contact person	SATOMI YANA
Organization	Japanese Society for Sentinel Node Navigation Surgery
Division name	Office
Address	35 Shinanomachi Shinjyuku-ku Tokyo JAPAN 160-8582
TEL	03-3353-6440
Homepage URL
Email	yanas@z7.keio.jp

Sponsor
Institute	Japanese Society for Sentinel Node Navigation Surgery
Institute
Department

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)

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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 20 Day
Anticipated trial start date	2018 Year 02 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	2017 Year 12 Month 25 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034889