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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007725
Receipt No. R000009082
Scientific Title Feasibility study of adjuvant nab-paclitaxel in breast cancer
Date of disclosure of the study information 2012/04/10
Last modified on 2012/04/10

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Basic information
Public title Feasibility study of adjuvant nab-paclitaxel in breast cancer
Acronym FANAP-BC Study
Scientific Title Feasibility study of adjuvant nab-paclitaxel in breast cancer
Scientific Title:Acronym FANAP-BC Study
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess the rate of the completion and safety of FEC followed by Nab-paclitaxel as adjuvant chemotherapy for breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Completion rate
Key secondary outcomes Safety,RDI,DFS

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 4 cycles of FEC followed by 4 cycles of Nab-paclitaxel
FEC:Epi 100mg/m2 and CPA 500mg/m2 and 5-FU 500mg/m2,day1 every 3weeks
Nab-paclitaxel:260mg/m2,day1 every 3weeks
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 Female patients with
1)Histologically confirmed invasive breast cancer patients
2)Lymph node metastases
3)Radical cure by operation
4)PS 0-2
5)Age>=20
6)No prior treatment for breast cancer
7)Required baseline laboratory data within 14days of registration
Hb>=8.0g/dL
WBC>=3000/mm3 and <=12000mm3
Neu>=2000/mm3
Plt>=100000/mm3
T-Bil<=1.5mg/dL
AST,ALT<100IU/L
Cre<=1.5mg/dL
8)Written informed consent
Key exclusion criteria 1)Serious drug hypersensitivity
2)Other any cancer
3)Other severe complications
4)Symptomatic brain metastasis
5)Severe mental disorders
6)Active bleeding of digestive tract
7)Serious myeloablation,renal insufficciency,liver failure
8)Massive hydrothorax or ascites
9)Diarrhea
10)Active infection
11)Allergy of the Nab-paclitaxel,paclitaxel or albumin
12)Pregnant
13)Serious Docetaxel and Polysorbate-80 hypersensitivity
14)Not suitable for participating in the study for any other reason
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nagashima
Organization Graduate school of medicine,Chiba University
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana,Chuo-ku,Chiba,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Sakakibara
Organization Graduate school of medicine,Chiba University
Division name Department of General Surgery
Zip code
Address 1-8-1 Inohana,Chuo-ku,Chiba
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Graduate school of medicine,Chiba University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 02 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 04 Month 10 Day
Last modified on
2012 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009082

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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