UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Title of the study (Brief title)	The study of evaluation that primary tumor resection influences to circulating tumor cells on Stage IV breast cancer(JCOG1017-A1)
Region	Japan

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

Objectives
Narrative objectives1	To determine the effect that primary tumor resection gives to circulating tumor cells exploratorily on Stage IV breast cancer
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	CTC-positive ratio, CTC-positive sustained ratio
Key secondary outcomes	CTC decrement, CTC decrease ratio

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Systemic therapy alone
Interventions/Control_2	B: Primary tumor resection plus systemic therapy
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	80 years-old >=
Gender	Female
Key inclusion criteria	1)first registration to JCOG1017 2)Within 14 days from the date of second registration 3)Witten informed consent
Key exclusion criteria	no exclusion criteria at second registration
Target sample size	160

Research contact person
Name of lead principal investigator	Hiroji Iwata
Organization	Aichi Cancer Center Hospital
Division name	Department of Breast Oncology
Address	1-1, Kanokoden, Chikusa-ku, Nagoya 464-8661, Japan
TEL	052-762-6111
Email	hiwata@aichi-cc.jp

Public contact
Name of contact person	Naoto Kondo
Organization	Naogya City University
Division name	Department of Oncology , Immunology & Surgery
Address	1 Kawasumi,Mizuho-cho,Mizuho-ku,Naogya 467-8601,Japan
TEL	052-853-8231
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 11 Day
Anticipated trial start date	2015 Year 10 Month 13 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	2016 Year 01 Month 14 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=R000023754