UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000603 |
|---|---|
| Receipt number | 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 18:05:57 |
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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
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/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000729
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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