UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007029 |
|---|---|
| Receipt number | R000008291 |
| Scientific Title | Feasibility study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (HBCC1101) |
| Date of disclosure of the study information | 2012/01/10 |
| Last modified on | 2015/01/06 13:32:55 |
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Basic information
Public title
Feasibility study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (HBCC1101)
Acronym
Feasibility study of weekly nab-paclitaxel in metastatic breast cancer (HBCC1101)
Scientific Title
Feasibility study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (HBCC1101)
Scientific Title:Acronym
Feasibility study of weekly nab-paclitaxel in metastatic breast cancer (HBCC1101)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of weekly nab-paclitaxel therapy for metastatic breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse drug reaction
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
Nab-paclitaxel 100mg/m2 on days 1, 8, 15
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
Female
Key inclusion criteria
1) Histological and/or cytological confirmed breast cancer
2) Metastatic breast cancer
3) Prior chemotherapy is up to 2 regimen
4) Women aged 20 and over
5) HER2 negative by IHC or FISH
6) ECOG performance status: 0-2
7) Adequate organ function
8) Expected survival longer than 90 days
9) Written informed consent to participate
Key exclusion criteria
1. Anamnesis of hypersensitivity to nab-paclitaxel, paclitaxel or albumin
2. Serious complication
3. Active double cancer
4. ECG abnormalities or heart failure with clinically problem
5. Recurrence under taxane treatment or within 12 months from last taxane dosage and progression under taxane treatment
6. Influence of an operation conducted within 4 weeks before registration is carried over
7. Use of radiation or pre-and/or post-surgical cytotoxic drug within 3weeks before registration
8. Use of hormonal drug within 2 weeks before registration
9. Past radiotherapy more than 30% of hematopoietic bone marrow
10. Peripheral neuropathy greater than grade 2
11. Active infectious disease which needs systemic treatment
12. Brain metastasis with symptom or brain metastasis needs medical treatment
13. Storage of pericardium liquid or storage of pleural effusion or ascites which needs drainage
14. Use of steroid regularly
15. Psychologic diseases and/or psychological symptoms
16. With pregnancy, lactation or the possibility of pregnancy
17. Use of investigational new drug within 4 weeks before registration
18. Unsuitable judgement by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Takahashi |
Organization
Hokkaido Cancer Center
Division name
Breast Surgery
Zip code
Address
4-2 Kikusui , Shiroishi-ku, Sapporo
TEL
011-811-9111
masatotk@sap-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Takahashi |
Organization
Hokkaido Cancer Center
Division name
Breast Surgery
Zip code
Address
4-2 kikusui shiroishiku Sapporo
TEL
011-811-9111
Homepage URL
masatotk@sap-cc.go.jp
Sponsor or person
Institute
Hokkaido Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Breast Cancer Consortium
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 | 01 | Month | 10 | 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
| 2011 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 06 | Day |
Last modified on
| 2015 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008291
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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