UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000869 |
|---|---|
| Receipt number | R000001045 |
| Scientific Title | A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer |
| Date of disclosure of the study information | 2007/10/30 |
| Last modified on | 2013/10/29 21:55:30 |
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Basic information
Public title
A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer
Acronym
KBCSG 0609 XP PhaseII
Scientific Title
A Phase II Study of Capecitabine plus Paclitaxel Combination Chemotherapy in Patients with Metastatic Breast Cancer
Scientific Title:Acronym
KBCSG 0609 XP PhaseII
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
To evaluate effectiveness and safety of Capecitabine plus Paclitaxel combination therapy in patients with Metastatic Breast Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rete
Key secondary outcomes
Time to treatment failure, Progression-free survival, Overall survival, Safety profiles
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, day1-21, q4w, Paclitaxel 80mg/m2, day1,8,15, q4w)
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Metastatic breast cancer
2) Measurable disease as per RECIST criteria
3) ECOG PS 0-1
4) 1 or less prior chemotherapy to metastatic breast cancer
5) Adequate bone marrow,hepatic,renal,cardiac functions
6) Expected survival time: more than 3 months
7) Written informed concent
Key exclusion criteria
1) Have Capecitabine before
2) Have Paclitaxel for metastatic lesion before
3) Hypersensitivity to drugs
4) active double cancer
5) severe complication
6) in pregnancy or lactation
7) Symptomatic brain metastasis
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
OSAKA NATIONAL HOSPITAL
Division name
Department of Surgery
Zip code
Address
2-1-14, Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL
06-6942-1331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinzaburo Noguchi |
Organization
KBCSG (Kinki Breast Cancer Study Group)
Division name
Executive Office
Zip code
Address
2-2, yamadaoka, suita-city, Oosaka
TEL
06-6879-3772
Homepage URL
Sponsor or person
Institute
KBCSG (Kinki Breast Cancer Study Group)
Institute
Department
Personal name
Funding Source
Organization
Non profit organization Epidemiological and Clinical Reserch Information Network
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 | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2006 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 29 | Day |
Last modified on
| 2013 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001045
