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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009267
Receipt No. R000010595
Scientific Title Feasibility study of Anthracycline Based Regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for elderly patients with breast cancer
Date of disclosure of the study information 2012/11/10
Last modified on 2012/11/06

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Basic information
Public title Feasibility study of Anthracycline Based Regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for elderly patients with breast cancer
Acronym FANAC study
Scientific Title Feasibility study of Anthracycline Based Regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for elderly patients with breast cancer
Scientific Title:Acronym FANAC 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 is to assess the feasibility and safety of Anthracycline based Regimen followed by Nab-paclitaxel as adjuvant chemotherapy for elderly patients with primary breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes feasibility
Key secondary outcomes safety, disease free 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 Anthracycline based regimen followed by 4 cycle nab-paclitaxel
Nab-paclitaxel:175mg/m2 intravenously administered on day 1 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
60 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria 1.Histoligically comfirmed Breast cancer
2.Age>=60 and Age<=80
3.Expeceted to radical cure by operation
4.Recieving adjuvant therapy with any anthracycline regimen
5.PS0 or 1
6.Patients who can receive nab-paclitaxel treatment within 8 weeks after anthracycline regimen
7.no adjuvant therapy except athracycline regimen
8.Patients who can correctly fill out a questionnaire
9.Required baseline laboratory parameters(within 14 days before registration):
Hb more than 9.0g/dl
WBC>=3000/mm3
Neu>=1500/mm3
Plt>=75000/mm3
AST,ALT<=ULNx2.5
T-Bil<1.5mg/dl
Crea<1.5mg/dl
10.adequate organ function
11.Written IC
Key exclusion criteria 1.History of severe allergy to nab-paclitaxel
2.Metachronous bilateral breast cancer
3.Active another cancer
4.History hypersensitivity reaction
5.Physician judged improper to entry this trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Itakura
Organization Shimane University Hospital
Division name Breast and endcrine surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane
TEL +81-853-20-2232
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimitsu Minari
Organization Shimane University Hospital
Division name Breast and endcrine surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane
TEL +81-853-20-2232
Homepage URL
Email minari@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
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 11 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
2012 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 10 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 11 Month 06 Day
Last modified on
2012 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010595

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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