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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007648
Receipt No. R000009019
Scientific Title A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer
Date of disclosure of the study information 2012/04/02
Last modified on 2016/05/11

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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 or without trastuzumab for node-positive breast cancer
Acronym EC-wnabPTX as NAC PII
Scientific Title A phase II study of neoadjuvant epirubicin/cyclophosphamide (EC) followed by weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab for node-positive breast cancer
Scientific Title:Acronym EC-wnabPTX as NAC PII
Region
Japan

Condition
Condition breast cancer
Classification by specialty
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 or without trastuzumab as a neoadjuvant therapy for the treatment of node-positive breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes pathological CR(pCR rate)
Key secondary outcomes the breast conserving rate, toxicities, feasibility and overall 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 In HER2negative cases, EC(E90mg/m2, C600mg/m2 4courses) followed by weekly nab-PTX(125mg/m2 on day1,8,15 in 28days 4courses) as a neoadjuvant therapy.
In HER2 posotive cases, EC(E90mg/m2, C600mg/m2 4courses) followed by weekly nab-PTX(125mg/m2 on day1,8,15 in 28days 4courses. weekly trastuzumab 2mg/kg) as a neoadjuvant therapy.
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 Male and Female
Key inclusion criteria Patients with histologically diagnosed invasive breast cancer
Resectable case
Category of the T1-4 N1-3
Without previous operation or chemotherapy
With measurable lesions
ECOG performance status 0-2

Adequate organ function
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 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Shimizu
Organization Tokyo Women&#39;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
Email shimitsu@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Hirano
Organization Tokyo Women&#39;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
Email ahirasu@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Women&#39;s Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Women&#39;s Medical University, Yachiyo Medical Center
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 東京女子医科大学東医療センター(東京都)、八千代医療センター(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 02 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 No longer recruiting
Date of protocol fixation
2011 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2018 Year 03 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
2012 Year 04 Month 02 Day
Last modified on
2016 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009019

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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