UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Title of the study (Brief title)	Breast cancer subtype and distant recurrences after ipsilateral breast tumor recurrences
Region	Japan

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

Objectives
Narrative objectives1	To evaluate whether breast cancer subtype is associated with distant recurrences after IBTR.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association of breast cancer subtype with distant recurrences after IBTR.
Key secondary outcomes

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	Male and Female
Key inclusion criteria	(1) patients who underwent breast-conserving surgery and axillary surgery (sentinel lymph node biopsy only was allowed if these nodes had no metastases); (2) patients who confirmed IBTR histologically; (3) patients who underwent definitive surgery for IBTR until 2008.
Key exclusion criteria	(1) synchronous (defined as occurring within 3 months) metastases;(2) bilateral breast cancer patients; (3) non-invasive tumor at IBTR specimen; (4) prior malignancy other than breast cancer; (5) patients with tumors located in the skin or muscle only without associated parenchymal disease; (6) patients who received neoadjuvant therapy at the initial treatment.
Target sample size	300

Research contact person
Name of lead principal investigator	Makoto Ishitobi
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Breast and Endocrine Surgery
Address	1-3-3, Nakamichi, higasinari-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person	Makoto Ishitobi
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Breast and Endocrine Surgery
Address
TEL
Homepage URL
Email

Sponsor
Institute	Collaborative Study Group of Scientific Research of the Japanese Breast Cancer Society
Institute
Department

Funding Source
Organization	The Japanese Breast Cancer Society
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	2012 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Clinico-pathological factors of primary breast cancer and ipsilateral breast tumor recurrences

Management information
Registered date	2012 Year 06 Month 11 Day
Last modified on	2017 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009580