UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009152
Receipt No. R000010730
Scientific Title Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer
Date of disclosure of the study information 2012/10/19
Last modified on 2013/10/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer
Acronym Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer
Scientific Title Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer
Scientific Title:Acronym Phase II study of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer
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 efficary and safty of FEC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Primary Breast Cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Pathological complete response rate
Key secondary outcomes Pathological response rate,Rasponse rate,Safty

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-ADM 90 mg/m2 and CPA 600 mg/m2 iv,day 1 every 3 weeks
Nab-paclitaxel
Nab-paclitaxel:100mg/m2 intravenously administred on day 1,8,15 every 4 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

Not applicable
Gender Female
Key inclusion criteria 1.Histologically confirmed Breast cancer
2. Clinical stage2-4
3. Expected to radical cure by operation and neoadjuvant chemotherapy
4. Has measurable region
5. Age >=20
6.No prior surgery, radiation, chemotherapy and endcrinethrapy
7.Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC >= 3500 /mm3 and <= 12,000 /mm3
Neu >= 2000 / mm3
Plt >= 100,000/mm3
T-Bil <= 2 times ULM
AST<= ULNx2
ALT<= ULNx2
Creatinin <=1.5 mg/dL
Ccr <=50 ml/min
8.Performance status 0-1
9. Oral administration is available
10.Written IC
Key exclusion criteria 1.Inflammatory and bilateral breast cancer
2.Active another cancer
3.History of hypersensitivity reaction
4. Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure
5. Contraindication to the study drugs
6. Has active infection or fever which suspected of infection
7.During administration of flucytosine, phenytoin, warfarin potassium
8.Physician judged improper to entry this trial
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsaku Kanazawa
Organization Toho University Omori Medical Center
Division name Breast and Endocrine Surgery
Zip code
Address 6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Email sg0713sk@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsaku Kanazawa
Organization Toho University Omori Medical Center
Division name Breast and Endocrine Surgery
Zip code
Address 6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Homepage URL
Email sg0713sk@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
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 10 Month 19 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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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 10 Month 19 Day
Last modified on
2013 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.