UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009616 |
|---|---|
| Receipt number | R000011281 |
| Scientific Title | Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer |
| Date of disclosure of the study information | 2012/12/24 |
| Last modified on | 2012/12/24 00:26:17 |
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Basic information
Public title
Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Acronym
Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Scientific Title
Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Scientific Title:Acronym
Study of combination chemotherapy of Albumin-bound paclitaxel / Cyclophosphamide in recurrent or metastatic breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate maximum tolerated dose and recommended dose of Cyclophosphamide and Albumin-bound paclitaxel combination chemotherapy for metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determinate maximum tolerated dose and recommended dose
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
Cyclophosphamide:600mg/m2 day1
Albumin-bound paclitaxel:150mg/m2-260mg/m2 day1 every 3 weeks
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
Female
Key inclusion criteria
1Histological confirmed primary breast cancer
2Reccurent,metastatic breast cancer
3No prior chemotherapy for metastasis, the recurrent breast cancer
4The case that passes after treatment of the adjuvant chemotherapy more than 24 weeks
5HER2 negative.
6An age of 20 years to 75 years
7ECOG Performance Status is 0 or 1
8Patient with measurable disease
9Required baseline laboratory data
10Expected survival time more than 60 days
11Written informed consent
Key exclusion criteria
1allergy of the medication
2Serious complications
3Previous or current history of malignant neoplasm
4Clinically significant heart disease
5Peripheral neuropathy grade2 or greater
6Active infection
7Symptomatic brain metastasis
8Uncontrollable pleural effusion or ascites requiring
9During administraton of pentostatin
10With mental disorder which become problem on clinical practice
11Current pregnancy or lacation,or possibility of pregnancy
12Cases who physician judged improper to entry this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57 Urafune-cho,Minami-ku,Yokohama City,232-0024,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Medical Center
Division name
Breast and thyroid surgery
Zip code
Address
4-57 Urafune-cho,Minami-ku,Yokohama City,232-0024,Japan
TEL
045-261-5656
Homepage URL
nri@gc5.so-net.ne.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
| 2012 | Year | 12 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 24 | Day |
Last modified on
| 2012 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011281
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
