UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012798 |
|---|---|
| Receipt number | R000014949 |
| Scientific Title | The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2-positive breast cancer |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2017/01/10 17:37:09 |
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Basic information
Public title
The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2-positive breast cancer
Acronym
The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2- positive breast cancer
Scientific Title
The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2-positive breast cancer
Scientific Title:Acronym
The safety and efficacy trial of nab-paclitaxel and trastuzumab as neoadjuvant chemotherapy for HER2- positive breast cancer
Region
| Japan |
Condition
Condition
HER2-positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of tri-weekly trastuzumab and nab-paclitaxel as neoadjuvant chemotherapy for HER2 positive breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Toxicity
Overall survival
Relapse 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
Nab-paclitaxl 260mg/mm2,q3w 6cycles
Trastuzumab 8mg/kg loading dose over 90 min and 6mg/kg second dose over 60 min then 6mg/kg subsequent doses over 30 min,q3w total 6cycles
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)HER2 overexpression(IHC3+ or IHC2+ and FISH positive)
3) Clinical stage IIA, IIB, IIIA
4) Age >= 20
5) PS (ECOG) 0, 1
6) LVEF more than 55%
7) Adequate organ function
8) Baseline laboratory parameters (within 14 days of registration)
Hemoglobin >= 9g/dL
WBC >= 4000/mm3
Neutrophil >= 2000/mm3
Platelet >= 100000/mm3
AST, ALT <= ULN*2.5
T-Bil <= 1.5mg/dL
Creatinine <= 1.5mg/dL
9) Written informed consent
Key exclusion criteria
1) Pregnant or lactating women
2) Invasive cancer after completion of therapy(less than 5years )
3) Asynchronous bilateral breast cancer
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Fujimori |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Department of breast surgery
Zip code
Address
3-20-1 Chuo,Ami Inashiki,Ibaraki
TEL
029-887-1161
minoruf@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Koshikawa |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Department of breast surgery
Zip code
Address
3-20-1 Chuo,Ami Inashiki,Ibaraki
TEL
029-887-1161
Homepage URL
kkoshi@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Ibaraki Medical Center
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
| 2014 | Year | 01 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 08 | Day |
Last modified on
| 2017 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014949
