UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Clinicopathological Factors in Patients with Resected Stage I-IIIA Breast Cancer (N-SAS-BC 01/CUBC Biomarker Study)
Acronym	Evaluation of Clinicopathological Factors in Patients with Resected Stage I-IIIA Breast Cancer
Scientific Title	Evaluation of Clinicopathological Factors in Patients with Resected Stage I-IIIA Breast Cancer (N-SAS-BC 01/CUBC Biomarker Study)
Scientific Title:Acronym	Evaluation of Clinicopathological Factors in Patients with Resected Stage I-IIIA Breast Cancer
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1) To evaluate the efficacy of adjuvant CMF and UFT for each IHC-based intrinsic subtype and the association of the amount of tumor-infiltrating lymphocytes with prognosis and treatment outcome by analyzing the relationship between clinicopathological factors and medical information (prognostic information) in patients with resected stage I-IIIA breast cancer. 2) To re-evaluate the NSAS Grading System, the grading criteria formulated during the NSAS-BC 01 study, by central review of pathological grades.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Relapse free survival
Key secondary outcomes	Overall survival

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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1)Subjects were selected from the 1054 patients enrolled and analyzed in the N-SAS-BC 01 and CUBC trials, and were included in the study if the applicable institutional review board authorized the sending of samples to other institutions for research, and if paraffin-embedded sections of surgically excised tumor tissue were available for that patient. 2)The institutions that participated in this study generally require that subject consent be obtained and a record of that consent be created prior to the start of a clinical study before they send a sample to another institution. However, in the event that it is not possible to obtain said consent because a patient is dead or cannot be contacted, samples may be sent to a central pathology review office if various provisions based on the Ethical Guidelines for Medical and Health Research Involving Human Subjects are met and authorization is obtained from each institutional review board and a representative of each participating institution.
Key exclusion criteria	1) Patients judged by their physician to be unfit to participate in this study 2) Patients who declined to consent to research use of their samples
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Ohno
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Breast Oncology Center
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	03-3520-0111
Email	shinji.ohno@jfcr.or.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Katakura
Organization	SRL Medisearch Inc.
Division name	Clinical Research Development
Zip code	1631310
Address	shinjuku I-Land-Tower 10F, 6-5-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	03-6692-0499
Homepage URL
Email	sme.n-sas_cubc@miraca.com

Sponsor
Institute	SRL Medisearch Inc.
Institute
Department

Funding Source
Organization	TAIHO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research Ethics Committee
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
Tel	03-3570-0210
Email	med.shinsa@jfcr.or.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

愛知県がんセンター中央病院（愛知県）、青森県立中央病院（青森県）、旭川医科大学病院（北海道）、岩国医療センター（山口県）、大分県立病院（大分県）、大阪警察病院（大阪府）、大阪国際がんセンター（大阪府）、大阪市立大学医学部附属病院（大阪府）、春日部市立病院（埼玉県）、神奈川県立がんセンター（神奈川県）、亀田総合病院（千葉県）、川崎医科大学附属病院（岡山県）、関西労災病院（兵庫県）、北九州市立医療センター（福岡県）、岐阜市民病院（岐阜県）、岐北厚生病院（岐阜県）、京都大学医学部附属病院（京都府）、近畿大学病院（大阪府）、釧路労災病院（北海道）、呉医療センター中国がんセンター（広島県）、群馬県立がんセンター（群馬県）、群馬大学医学部附属病院（群馬県）、慶應義塾大学病院（東京都）、厚生連高岡病院（富山県）、国立国際医療研究センター病院（千葉県）、九州医療センター（福岡県）、国立病院機構 九州がんセンター（福岡県）、埼玉県立がんセンター（埼玉県）、さいたま赤十字病院（埼玉県）、埼玉メディカルセンター（埼玉県）、静岡県立総合病院（静岡県）、東京女子医科大学東医療センター（東京都）、市立東大阪医療センター（大阪府）、聖隷浜松病院（静岡県）、聖路加国際病院（東京都）、千葉県がんセンター（千葉県）、東北大学病院（宮城県）、徳島大学病院（徳島県）、栃木県立がんセンター（栃木県）、虎の門病院（東京都）、長崎みなとメディカルセンター市民病院（長崎県）、名古屋市立大学病院（愛知県）、名古屋大学医学部附属病院（愛知県）、日本赤十字社医療センター（東京都）、浜松医療センター（静岡県）、県立広島病院（広島県）、福岡大学病院（福岡県）、福島県立医科大学医学部（福島県）、星総合病院（福島県）、国立病院機構 北海道がんセンター（北海道）、松山赤十字病院（愛媛県）、三井記念病院（東京都）、八尾市立病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Related information
URL releasing protocol	N/A
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s10549-020-06018-1
Number of participants that the trial has enrolled	707
Results	HR+/HER2-: 10yr RFS CMF:81.2% UFT:76.7% 10yr OS CMF:89.5% UFT:91.0% HR-/HER2-: 10yr RFS CMF:84.7% UFT:78.2% 10yr OS CMF:89.4% UFT:84.6% HR+/HER2+: 10yr RFS CMF:73.7% UFT:71.4% 10yr OS CMF:68.4% UFT:81.2% HR-/HER2+: 10yr RFS CMF:73.7% UFT:71.4% 10yr OS CMF:78.9% UFT:90.9%
Results date posted	2021 Year 07 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 12 Month 01 Day
Baseline Characteristics	CMF 342 patients, UFT 34 patients
Participant flow	706 specimens were collected; 689 cases were included in the analysis after excluding 17 patients determined to be DCIS
Adverse events	N/A
Outcome measures	RFS, OS
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 02 Month 12 Day
Date of IRB	2016 Year 02 Month 12 Day
Anticipated trial start date	2018 Year 05 Month 31 Day
Last follow-up date	2019 Year 01 Month 16 Day
Date of closure to data entry	2019 Year 03 Month 13 Day
Date trial data considered complete	2019 Year 03 Month 14 Day
Date analysis concluded	2019 Year 11 Month 14 Day

Other

Other related information

Study design: cross-sectional method Subjects: Subjects were the 1054 patients enrolled and analyzed in the N-SAS-BC 01 and CUBC trials. In the N-SAS-BC 01 trial, patients were enrolled between October 1996 and April 2001 In the CUBC trial, patients were enrolled between September 1996 and July 2000. Evaluation items: ER, PgR, HER2, Ki67, Tumor infiltrating lymphocyte(Tils), Nuclear grading, Histological grading

Management information
Registered date	2016 Year 06 Month 01 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026003