UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006428 |
|---|---|
| Receipt number | R000007631 |
| 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 | 2011/09/28 |
| Last modified on | 2016/04/01 11:23:54 |
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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: 260mg/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
| 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 | Syunsuke Magoshi |
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
magoshi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syunsuke Magoshi |
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
magoshi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
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
| 2011 | Year | 09 | Month | 28 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2016 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007631
