UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038715 |
|---|---|
| Receipt number | 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 18:43:50 |
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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
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
sur067@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044135
