UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting
Title of the study (Brief title)	A feasibility study of dose-dense chmotherapy for primary breast cancer
Region	Japan

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

Objectives
Narrative objectives1	To verify the feasibility of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relative dose intensity
Key secondary outcomes	Adverse events To evaluate the accumulation of pegfirugrasutim

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	A chemotherapy treatment plan in which drugs are given with less time between treatments than in a standard chemotherapy treatment plan.
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	75 years-old >=
Gender	Female
Key inclusion criteria	Patients with primary breast cancer who had been decided to treat epirubicin and cyclophosphamide in neoadjuvant or adjuvant setting. Additional eligibility criteria for enrollement include: having no evidence of metastatic disease, having the following laboratory values: absolute neutrophil count >=1500/mm3, hemoglobin >=9.0g/dl, platelets >=100,000/mm3, aspartate aminotransferase and alanine aminotransferase <=100IU/ml, serum bilirubin <=1.5mg/dl, serum creatinine <=1.5mg/dl, being no cardiac dysfunction on ECG and US, having an Eastern Cooperative Oncoligy Group performance status of O or 1, and having been written informed consent.
Key exclusion criteria	Patients with active infection need to treat systemic therapy, nursing, mental disorder, or other uncontrolled medical conditions are excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	Yuichi Ando
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560 Japan
TEL	052-744-1903
Email	yando@med.nagoya-u.ac.jp

Public contact
Name of contact person	Sachi Morita
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560 Japan
TEL	052-744-1903
Homepage URL
Email	s-kamei@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Management Expenses Grants
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 01 Month 28 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 12 Month 27 Day
Anticipated trial start date	2015 Year 02 Month 11 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	Published
URL releasing results	https://link.springer.com/article/10.1007/s10147-017-1177-z
Results
Other related information

Management information
Registered date	2015 Year 01 Month 14 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018742