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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012798
Receipt No. 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

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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
Email 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
Email kkoshi@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Ibaraki Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014949

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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