UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility Study to Assess Diagnostic Accuracy of Pathological Complete Response with Core Needle Biopsy
Title of the study (Brief title)	CNB for Breast Cancer Acquired cCR with NAC
Region	Japan

Condition
Condition	Invasive Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess feasibility of diagnostic accuracy of pathological complete response (pCR) with core needle biopsy(CNB) for breast cancer patient who acquired clinical complete response (cCR) with neoadjuvant chemothrapy. If pCR is diagnosed with CNB correctly, we have opportunity to omit surgical procedure for resection.
Basic objectives2	Others
Basic objectives -Others	Feasibility study to assess diagnostic accuracy of pathological complete response with core needle biopsy.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy of pCR with CNB
Key secondary outcomes	Accuracy of pCR with imaging study.

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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Core needle biopsy is performed just before resection of the primary lesion under general anesthegia for the resection procedure.
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	75 years-old >
Gender	Female
Key inclusion criteria	1) Woman age of 20 to 75 years old at registration. 2) Invasive breast cancer proven by core biopsy. 3) Negative for estrogen receptor immunohistochemically. 4) No prior therapy including radiation, endocrine therapy or immunotherapy except for neoadjuvant chemotherapy for existing breast cancer. 5) Expected complete response for invasive cancer by neoadjuvant chemotherapy with imaging study. 6) Informed consent must be obtained before patient registration.
Key exclusion criteria	1) Male gender 2) Judged to be inadequate by the doctor.
Target sample size	80

Research contact person
Name of lead principal investigator	Kazutaka Narui
Organization	Yokohama City University Medical Center
Division name	Department of Breast and Thyroid Surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	nr1@gc5.so-net.ne.jp

Public contact
Name of contact person	Kazutaka Narui
Organization	Yokohama City University Medical Center
Division name	Department of Breast and Thyroid Surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	nr1@gc5.so-net.ne.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	横浜市立大学附属市民総合医療センター（神奈川県） 東海大学付属病院（神奈川県） 聖マリアンナ医科大学病院（神奈川県） 聖マリアンナ医科大学ブレスト＆イメージング（神奈川県） 北里大学病院（神奈川県） 神奈川県立がんセンター（神奈川県） 大船中央病院（神奈川県） 横浜労災病院（神奈川県） 湘南記念病院（神奈川県） 横浜市立みなと赤十字病院（神奈川県） 横浜旭中央総合病院（神奈川県） 東海大学付属八王子病院（神奈川県） 横浜市立大学附属病院（神奈川県） 弘前市立病院（青森県） 東京医科大学八王子医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 04 Day
Anticipated trial start date	2013 Year 10 Month 15 Day
Last follow-up date	2015 Year 09 Month 30 Day
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	2013 Year 10 Month 15 Day
Last modified on	2018 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014067