UMIN-CTR Clinical Trial

Basic information
Public title	TOPS
Acronym	TOPS
Scientific Title	Identification of high-risk groups for ipsilateral breast tumor recurrence among candidates for omission of breast surgery
Scientific Title:Acronym	Identification of high-risk groups for ipsilateral breast tumor recurrence
Region	Japan

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

Objectives
Narrative objectives1	To assess the risk factors of ipsilateral breast tumor recurrence (IBTR) among breast cancer patients who received neoadjuvant chemotherapy (NAC) and breast-conserving treatment (BCT) and obtained pathological complete response (pCR).
Basic objectives2	Others
Basic objectives -Others	risk evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	IBTR rate
Key secondary outcomes	Identification of high- or low-risk groups of IBTR

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Triple-negative or HER2-positive breast cancer patients who received NAC and BCT and obtained pCR
Key exclusion criteria	Stage 4 breast cancer patients Patients who had tumorectomy before NAC
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Ishitobi
Organization	Osaka International Cancer Institute
Division name	Departments of Breast and Endocrine Surgery
Zip code	541-8567
Address	3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL	0669451181
Email	isitobi-ma@mc.pref.osaka.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ishitobi
Organization	Osaka International Cancer Institute
Division name	Departments of Breast and Endocrine Surgery
Zip code	541-8567
Address	3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL	0669451181
Homepage URL
Email	isitobi-ma@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel	0669451181
Email	rinri01@opho.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

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 14 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	Completed
Date of protocol fixation	2019 Year 01 Month 04 Day
Date of IRB	2019 Year 01 Month 04 Day
Anticipated trial start date	2019 Year 01 Month 04 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 12 Month 15 Day

Other
Other related information	multicenter retrospective cohort study

Management information
Registered date	2019 Year 06 Month 14 Day
Last modified on	2021 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042239