UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of capecitabine plus irinotecan for metastatic breast cancer patient who pretreated with anthracycline and taxane agents
Title of the study (Brief title)	CAPIRI-Breast
Region	Japan

Condition
Condition	metastatic breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes

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	Capecitabine plus irinotecan
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	Male and Female
Key inclusion criteria	1)metastatic breast cancer 2)patient who had received both anthracycline and taxane agents
Key exclusion criteria	1)Patient have no indication of chemotherapy 2)patient who have priortreated with capecitabine or irinotecan
Target sample size	30

Research contact person
Name of lead principal investigator	Masashi Ando
Organization	National cancer center hospital
Division name	Breast and Medical Oncology
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
Organization	National cancer center hospital
Division name	Breast and Medical Oncology
Address
TEL
Homepage URL
Email

Sponsor
Institute	National cancer center hospital
Institute
Department

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	2008 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2005 Year 04 Month 01 Day
Anticipated trial start date	2005 Year 05 Month 01 Day
Last follow-up date	2011 Year 10 Month 01 Day
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	2008 Year 11 Month 26 Day
Last modified on	2017 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001848