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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038715
Receipt No. R000044135
Scientific Title Phase II neoadjuvant trial of nab-Paclitaxel+Pertuzumab+Trastuzumab followed by Anthracycline based regimen in patients with operable Her2 positive breast cancer
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/28

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Basic information
Public title Phase II neoadjuvant trial of nab-Paclitaxel+Pertuzumab+Trastuzumab followed by Anthracycline based regimen in patients with operable Her2 positive breast cancer
Acronym OMC-BC05 Study
Scientific Title Phase II neoadjuvant trial of nab-Paclitaxel+Pertuzumab+Trastuzumab followed by Anthracycline based regimen in patients with operable Her2 positive breast cancer
Scientific Title:Acronym OMC-BC05 Study
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of neoadjuvant nab-Paclitaxel+Pertuzumab+Trastuzumab followed by Anthracycline based regimen in operable 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
Key secondary outcomes disease free survival
objective response rate
histological response rate
breast conserving rate
safety
rate of peripheral neuropathy

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 All patients undergo nab-Paclitaxel + Pertuzumab+Trastuzumab followed by Anthracycline based regimen
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Her2 positive operable breast cancer
Key exclusion criteria none
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Mitsuhiko
Middle name
Last name Iwamoto
Organization Osaka Medical College
Division name Department of Breast Surgery
Zip code 5698686
Address 2-7 Daigakucho, Takatsuki, Osaka
TEL +81726831221
Email sur067@osaka-med.ac.jp

Public contact
Name of contact person
1st name Mitsuhiko
Middle name Iwamoto
Last name Mitsuhiko
Organization Osaka Medical College
Division name Department of Breast Surgery
Zip code 5698686
Address 2-7 Daigakucho, Takatsuki, Osaka
TEL +81726831221
Homepage URL
Email sur067@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Self funding
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 Osaka Medical College
Address 2-7 Daigakucho, Takatsuki, Osaka
Tel +81726831221
Email sur067@osaka-med.ac.jp

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
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2024 Year 12 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
2019 Year 11 Month 28 Day
Last modified on
2019 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044135

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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