UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013886 |
|---|---|
| Receipt number | R000015990 |
| Scientific Title | A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer |
| Date of disclosure of the study information | 2014/05/06 |
| Last modified on | 2016/05/11 10:02:17 |
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Basic information
Public title
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer
Acronym
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer
Scientific Title
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer
Scientific Title:Acronym
A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this phase II study is to evaluate the efficacy and toxicity of EC (epirubicin/cyclophosphamide) followed by weekly nab-PTX with trastuzumab as a neoadjuvant therapy 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 CR(pCR) rate
Key secondary outcomes
The breast conserving rate, toxicities, feasibility, overall survival, and 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
Patients receive four cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks, followed by four cycles of nab-PTX (100 mg/m2) on days 1, 8 and 15 in a 28-day cycle. Fifteen cycles of trastuzumab (2 mg/kg, loading 4 mg/kg) are added to the nab-PTX regimen every week.
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)Patients with histologically diagnosed invasive breast cancer.
2)Resectable case
3)Category of the T2-4, N0-3, M0.
4)Without previous operation or chemotherapy
5)With measurable lesions
6)ECOG performance status 0-2
7)Adequate organ function
8)Written informed concent
Key exclusion criteria
Severe complications
history of hypersensitivity reaction for important drug in this study
Bilateral breast cancer
Inflammatory breast cancer
Pregnant or nursing women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Shimizu |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Department of Breast Surgery
Zip code
Address
2-1-10, Nishi-ogu, Arakawa-ku,
TEL
03-3810-1111
shimitsu@dnh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hirano |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Department of Breast Surgery
Zip code
Address
2-1-10, Nishi-ogu, Arakawa-ku,
TEL
03-3810-1111
Homepage URL
ahirasu@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Women's Medical University, Yachiyo Medical Center
Name of secondary funder(s)
None
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
東京女子医科大学東医療センター（東京都）、東京女子医科大学八千代医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 06 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015990
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