UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000022
Receipt No. R000000030
Scientific Title Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
Date of disclosure of the study information 2005/07/07
Last modified on 2011/07/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
Acronym XC phase 2 study for MBC
Scientific Title Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
Scientific Title:Acronym XC phase 2 study for MBC
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 The purpose of this study is to evaluate the feasiblity and safety of capecitabine-cyclophospamide combination for metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival(PFS), overall survival(OS), 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 chemotherapy
capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles
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
74 years-old >=
Gender Female
Key inclusion criteria 1)Inoperable advanced or recurrent breast cancer
2)Negative HER2 status (0 or 1+ by immunohistochemistry or negative by FISH)
3)Required to have received previous systemic chemotherapy containing the anthracycline
4)No previous systemic chemotherapy with taxanes or oral doxifludine/cyclophosphamide combination.
Permitted to enter this trial, only if more than one year passed after the completion of preoperative or
postoperative settings using these drugs.
5)Performance status of 0, 1, or 2
6)Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function
7)Written informed consent is required to obtain from each patient at each participating institution
Key exclusion criteria 1)Pregnant or breast feeding
2)Documented history of serious hypersensitivity reaction on the medical drugs
3)Patients who have experienced prior chemotherapy with capecitabine
4)With metastasis to the central nervous system
5)Serious underlying medical illness with heart, gastrointestinal tract, or infection
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shousyu Mitsuyama
Organization Kitakyusyu Municipal Medical Center
Division name Surgery
Zip code
Address 1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyusyu Japan
TEL 093-541-1831
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyushu Breast Cancer Study Group
Division name Executive Office
Zip code
Address 45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka Japan
TEL 092-801-1011
Homepage URL
Email ktamura@fukuoka-u.ac.jp

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

Funding Source
Organization Non profit organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization Non profit foundation
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
2005 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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
2005 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2005 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
2010 Year 06 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 07 Day
Last modified on
2011 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000030

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.