UMIN-CTR Clinical Trial

Basic information
Public title	Cohort Study on Febrile Neutropenia in Adjuvant Chemotherapy for Breast Cancer Patients
Acronym	FN Study on Adjuvant Chemotherapy for Breast Cancer
Scientific Title	Cohort Study on Febrile Neutropenia in Adjuvant Chemotherapy for Breast Cancer Patients
Scientific Title:Acronym	FN Study on Adjuvant Chemotherapy for Breast Cancer
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To observe the frequency and risk factors of febrile neutropenia on (neo-)adjuvant chemotherapy for breast cancer patients
Basic objectives2	Others
Basic objectives -Others	In stage I-III breast cancer patients treated by high risk chemotherapies for febrile neutronenia, its frequency and risk factors are observed prospectively
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of Febrile Neutropenia
Key secondary outcomes	1) FN in 1st. cycle 2)Grade 4 FN 3)Hospitalization 4) G-CSF 5)Antibiotics 6)Adverse events with FN and RDI 7) Patients with G-CSF 8) FN with or without G-CSF 9) Severe adverse events

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. Female patients with invasive ductal and lobular breast cancer 2. Stage I - III 3. Patients receiving (neo)adjuvant chemotherapy with risk of FN
Key exclusion criteria	Patients with no chemotherapy
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Ishikawa
Organization	Tokyo Medical University
Division name	Breast Surgery
Zip code
Address	6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo 160-0023
TEL	0333426111
Email	tishik55@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Kaise
Organization	Tokyo Medical University
Division name	Breast Surgery
Zip code
Address	6-7-1
TEL	0333426111
Homepage URL
Email	tishik55@gmail.com

Sponsor
Institute	CSPOR-BC
Institute
Department

Funding Source
Organization	Kyouwa Hakko Kirin
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
Address
Tel
Email

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	2015 Year 06 Month 15 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	2015 Year 04 Month 27 Day
Date of IRB	2015 Year 04 Month 28 Day
Anticipated trial start date	2015 Year 07 Month 15 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information	Prospective cohort study on frequency and risk factors of febrile neutropenia in neo- and adjuvant chemotherapy for breast cancer patients

Management information
Registered date	2015 Year 06 Month 10 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020512