UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022097 |
|---|---|
| Receipt number | R000024792 |
| Scientific Title | Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer |
| Date of disclosure of the study information | 2016/04/28 |
| Last modified on | 2017/10/28 10:06:09 |
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Basic information
Public title
Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer
Acronym
Feasibility study of Dose-Dense therapy for early breast cancer
Scientific Title
Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer
Scientific Title:Acronym
Feasibility study of Dose-Dense therapy for early 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
To verify a feasibility of neoadjuvant Dose-Dense A(E)C followed by PTX for axillary node-positive, HER2 negative early breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
pathological Complete Response rate
Key secondary outcomes
safety (morbidity rate of febrile neutropenia, rate of accomplishment)
overall response rate
toxicity profile
Relative Dose Intensity(RDI)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. written informed consent
2. more than 20 y.o to 70y.o
3. ECOG PS 0-2
4. diagnosis of invasive breast cancer
5.HER2 negative
6. more than cN1
7. visceral function
8. LVEF more than 50%
Key exclusion criteria
1. distant metastasis
2. pregnancy or breast feeding
3. history of drug allergy
4. active infection
5. uncontrollable psychosis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Takabatake |
Organization
Kochi Health Science Center
Division name
breast surgery
Zip code
Address
2125-1 Ike Kochi
TEL
088-837-3000
bata@khsc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadahiko Shien |
Organization
Okayama University Hospital
Division name
breast surgery
Zip code
Address
2-5-1 shikata Okayama
TEL
086-235-7265
Homepage URL
yshien@md.okayama-u.ac.jp
Sponsor or person
Institute
NPO Setouchi Breast Project
Institute
Department
Personal name
Funding Source
Organization
NPO Setouchi Breast Project
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
多施設共同
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
preinitiation
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024792
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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