UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study evaluating the safety of dose-dense EC with pegfilgrastim.
Title of the study (Brief title)	A study evaluating the safety of dose-dense EC with pegfilgrastim.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of ddEC with pegfilgrastim.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	rate of severe adverse event
Key secondary outcomes	rate of febrile neutropenia, oher adverse event

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	ddEC therapy; epirubicine 90mg/m2 Day1 cyclophosphamide 600mg/m2 Day1 PEG-filgrastim 3.6mg Day4 q14, 4 cycle evaluate at 3 months afer the last registration.
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	70 years-old >
Gender	Female
Key inclusion criteria	1 Patients requiring ddEC therapy 2 informed consent 3 EF>50 4 20<=age<70 5 ECOG PS: 0-1
Key exclusion criteria	1 allergic for G-CSF 2 a case of active infection 3 pregnancy or breast-feeding 4 severe comobidity
Target sample size	10

Research contact person
Name of lead principal investigator	Shinichiro Kubo
Organization	Fukuyama city hospital
Division name	Department of Breast and thyroid surgery
Address	5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL	084-941-5151
Email	shikubo@city.fukuyama.hiroshima.jp

Public contact
Name of contact person	Shinichiro Kubo
Organization	Fukuyama city hospital
Division name	Department of Breast and thyroid surgery
Address	5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL	084-941-5151
Homepage URL
Email	shikubo@city.fukuyama.hiroshima.jp

Sponsor
Institute	Fukuyama city hospital
Institute
Department

Funding Source
Organization	none
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	2016 Year 02 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 02 Day
Anticipated trial start date	2015 Year 12 Month 02 Day
Last follow-up date	2017 Year 07 Month 13 Day
Date of closure to data entry	2017 Year 07 Month 13 Day
Date trial data considered complete	2017 Year 07 Month 13 Day
Date analysis concluded	2017 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2018 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023652