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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013275
Receipt No. 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

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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
Email 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
Email tsutomu-@rd5.so-net.ne.jp

Sponsor
Institute Department of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007805

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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