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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009733
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima city 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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011410

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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