UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	oral CEF(Cyclophosphamide, Epirubicin, UFT) adjuvant chemotherapy for breast cancer with intra-patient dose escalation
Title of the study (Brief title)	Oral CEF adjuvant chemotherapy
Region	Japan

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

Objectives
Narrative objectives1	Determination of initial recommended dose of Cyclophosphamide(CPA) and UFT in oral CEF outpatient chemotherapy with intra-patient dose escalation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Maximum tolerated dose (MTD) in oral CEF chemotherapy with intra-patient dose escalation
Key secondary outcomes	Disease free survival time Adverse events graded by CTC

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Adjuvant chemotherapy with oral cyclophosphamide and UFT with intra-patient dose escalation (Epirubicin)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	69 years-old >=
Gender	Female
Key inclusion criteria	Female with pathologically proven primary breast cancer Clinical stage 1,2, 3A(TNM) PS(ECOG) 0~1 Within 12 weeks of breast surgery No prior chemo-endocrine therapy No adjuvant radiotherapy Preserved major organ function Written informed consent
Key exclusion criteria	Infection, Fever = or > 38C Serious comorbidity Interstitial pneumonitis/fibrosis Peripheral neuropathy/edema Positive HBsAg Prior use of Anthracycline Decision by primary physician
Target sample size	26

Research contact person
Name of lead principal investigator	Hiroshi Ishiguro, MD, PhD
Organization	Kyoto University Hospital
Division name	Outpatient Oncology Unit
Address	54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL	075-751-4770
Email	hkkishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroshi Ishiguro, MD, PhD
Organization	Kyoto University Hospital
Division name	Outpatient Oncology Unit
Address	54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL	075-751-4770
Homepage URL
Email	hkkishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Outpatient Oncology Unit Kyoto University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2006 Year 06 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 06 Month 14 Day
Anticipated trial start date	2006 Year 07 Month 01 Day
Last follow-up date	2013 Year 06 Month 01 Day
Date of closure to data entry	2013 Year 07 Month 01 Day
Date trial data considered complete	2013 Year 08 Month 01 Day
Date analysis concluded	2013 Year 09 Month 01 Day

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

Management information
Registered date	2006 Year 06 Month 14 Day
Last modified on	2016 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000521