UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009267 |
|---|---|
| Receipt number | 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 12:55:52 |
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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
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
minari@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010595
