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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000603
Receipt No. R000000729
Scientific Title Multicenter phase II trial of weekly-paclitaxel and oral capecitabine combination therapy for metastatic breast cancer
Date of disclosure of the study information 2007/02/09
Last modified on 2017/11/30

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Basic information
Public title Multicenter phase II trial of weekly-paclitaxel and oral capecitabine combination therapy for metastatic breast cancer
Acronym Phase II study of paclitaxel plus capecitabine (XP) for metastatic breast cancer
Scientific Title Multicenter phase II trial of weekly-paclitaxel and oral capecitabine combination therapy for metastatic breast cancer
Scientific Title:Acronym Phase II study of paclitaxel plus capecitabine (XP) for metastatic breast cancer
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is to
estimate PFS and examine the execution possibility of weekly paclitaxel/oral capecitabine combination therapy for patient with 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 Progression Free Survival (PFS)
Key secondary outcomes adverse event
overall survival (OS)
Time To Progression (TTF)
Response rate, PFS and OS for breast cancer with ER/PgR/HER2 negative

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 1) Paclitaxel 80mg/m2 (day 1,8 q3W)

2) Capecitabine 1650mg/m2 (day 1-14 followed by a week rest q3W)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically confirmed breast carcinoma.
2. clinically distant metastasis
3. previous teatment is nothing or only 1st line chemotherapy. (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen)
4. Age>=20
5. PS(ECOG) 0-1
6. Written informed consent
7. expected survival time: more than 6 months
8. Adequate organ function

Key exclusion criteria 1. severe complication
2. The brain metastasis which possesses condition
3. Past history of allergic reaction
4. Past history of allergic reaction to cremophor EL (polyoxyethylated castor oil) or polysorbate
5. which has the use history of taxane or 5' DFUR or capecitabine (but the case, after taxane is prescribed in adjuvant or neo ajuvant 6months or more has elapsed, is the register possible not in addition to 1 regimen).
6. Peripheral neuropathy >= grade 2 in prior chemotherapy
7. Pregnant or lactating women
8. Doctor's decision for exclusion
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Tabei
Organization Saitama Cancer Center
Division name Endocrinology
Zip code
Address 818 Komuro Ina Kitaadachi, Saitama 362-0806
TEL 048-722-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name Executive office
Zip code
Address 1550 Katayanagi Minuma Ward Saitama City, Saitama 337-0024
TEL 048-686-7155
Homepage URL http://www.sbccsg.org/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group (SBCCSG)
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)

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
2007 Year 02 Month 09 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 Terminated
Date of protocol fixation
2007 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
2008 Year 06 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2008 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 02 Month 08 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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