UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013275 |
|---|---|
| Receipt number | R000007805 |
| Scientific Title | Prospective cohort study for safety and efficacy of low dose nab-paclitaxel |
| Date of disclosure of the study information | 2014/02/25 |
| Last modified on | 2017/11/10 15:59:30 |
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Basic information
Public title
Prospective cohort study for safety and efficacy of low dose nab-paclitaxel
Acronym
Cohort study of low dose nab-paclitaxel
Scientific Title
Prospective cohort study for safety and efficacy of low dose nab-paclitaxel
Scientific Title:Acronym
Cohort study of low dose nab-paclitaxel
Region
| Japan |
Condition
Condition
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 safety and efficacy of low dose tri-weekly nab-paclitaxel (175mg/m2) in metastatic breast cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Time to progression
Overall response rate
Overall survival
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 is administered by drip infusion over 30 minutes in day 1 of 21 days cycle.
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) Histologically diagnosed female breast cancer patients
2) Inoperable or recurrent breast cancer patients
3) Age moer than 20 and less than 80 years old
4) Performance status 0 or 1 (ECOG)
5) Never treated with paclitaxel for metastatic disease.
6) Adequate major organ functions.
WBC more than 4000/mm3 and
less than 12000/mm3
Neutrophil more than 2000/mm3
Platelet more than 100000/mm3
Hemoglobin more than 9.0 g/dL
AST, ALT less than 100 IU/L
Total bilirubin less than 1.5 mg/dL
Creatinine less than 1.5 mg/dL
Normal ECG
7) The patients that an agreement of perticipation
was obtained in a document
Key exclusion criteria
1) Past history of hypersensitivity for human serum
albumin
2) Infectious disease that required systemic therapy
3) History of a severe heart disease
4) Poorly controlled diabetes mellitus
5) Peptic ulcer or gastrointestinal hemorrhage
6) Symptomatic brain metastsis
7) Pregnant, Lactating or possibility of pregnancy
8) History of drug allergy that may influenced with this
treatment
9) In addition, the case that a investigator judged to
be inadequate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL
06-6645-3838
tsutomu-@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL
06-6645-3838
Homepage URL
tsutomu-@rd5.so-net.ne.jp
Sponsor or person
Institute
Department of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgical Oncology Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
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
大阪市立大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2014 | Year | 02 | Month | 25 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007805
