UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009733 |
|---|---|
| Receipt number | R000011410 |
| Scientific Title | A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer |
| Date of disclosure of the study information | 2013/01/15 |
| Last modified on | 2018/09/18 23:07:59 |
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Basic information
Public title
A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Acronym
A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Scientific Title
A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Scientific Title:Acronym
A phase 2 study of nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of nab-paclitaxel followed by FEC for the treatment of operable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response rate
Key secondary outcomes
response rate,safety
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 nab-paclitaxel followed by 4 cycles of FEC
Nab-paclitaxel
nab-paclitaxel: 260mg/m2, iv, day 1
every 3 weeks
FEC
Epi-ADM 90 mg/m2 and CPA 600 mg/m2 iv,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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically confirmed Breast cancer
2) Clinical T1-3, N0-2, M0 cases and expected to radical cure by operation and neoadjuvant chemotherapy
3) ER,PgR and HER2 statuses are confirmed by needle biopsy
4) Age between 20 and 70 years
5) has measurable region
6) No prior therapy for present primary breast cancer
7) ECOG performance status 0 to 1
8) Required baseline laboratory parameters (within 2 weeks before registration):
WBC 12,000 /mm3> >= 4000 /mm3
Neu >= 2000 / mm3
Plt >= 100,000/mm3
Hb >= 10.0g/dl
AST <= ULNx2.5
ALT <= ULNx2.5
T-Bil <= 1.5mg/dL
Creatinin <=1.5 mg/dL
ECG normal
9) Written IC
Ccr <=50 ml/min
Key exclusion criteria
1) with history of cardiac dysfunction
2) with sever complications
ex.)with incontrollable diabetes,with infection,hypertension, renal insufficiency, liver failure and mental disorder which become problem on clinical practice
3) during pregnancy or lactation
4) with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) .
5) with bilateral breast cancer
6) with pulmonary fibrosis or pneumonitis
7) allergy of the nab-Paclitaxel,
Epirubicin,Cyclophosphamide and Fluorouracil
8) with peripheral neuropathy
9) HBs antigen is positive
10) patients judged by the investigator as unfit to be enrolled in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ootani |
Organization
Hiroshima city hospital
Division name
Breast surgery
Zip code
Address
7-33 Moto-machi Naka-ku Hiroshima-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima city hospital
Division name
Breast surgery
Zip code
Address
TEL
082-221-2291
Homepage URL
Sponsor or person
Institute
Hiroshima city 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
| 2013 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 16 | 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
| 2013 | Year | 01 | Month | 09 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011410
