UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014351 |
|---|---|
| Receipt number | R000016703 |
| Scientific Title | Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer. |
| Date of disclosure of the study information | 2014/06/24 |
| Last modified on | 2018/11/19 15:34:39 |
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Basic information
Public title
Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Acronym
Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Scientific Title
Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Scientific Title:Acronym
Phase II Neoadjuvant Study of EC followed by Abraxane in opetable breast cancer.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is a phase II neoadjuvant study aimed to evaluate the effect and safety of EC followed by Abraxane as neoadjuvant therapy in operable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response (pCR)
Key secondary outcomes
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
EC followed by Abraxane
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)infiltrating primary breast cancer
2)T1-3, N0-2, M0, neoadjuvant setting, operable breast cancer
3)confirmed ER/PgR/HER2
4)20-75 years old, femal
5)measureble lesion(PECIST version 1.1)
6)previously untreated
7)performance status(PS) 0-1
8)maintained organs function: omit
9)informed concent
Key exclusion criteria
1)cardiac dysfunction
2)severe complication(uncontoroled DM, hypertension, renal failure, hepatic failure, severe infection, mental disorder)
3)pregnancy, lactation
4)double cancer
5)bilateral breast cancer
6)pulmonary fibrosis, interstitial pneumonia
7)allergy
8)neuropathy
9)HBs antigen positive
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Yaqmamoto |
Organization
Kawasaki Medical School
Division name
Breast Thyroid Surgery
Zip code
Address
577, Matsushima Kurashiki Okayama
TEL
086-462-1111
yamayou@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Yamamoto |
Organization
Kawasaki Medical School
Division name
Breast Thyroid Surgery
Zip code
Address
577, Matsushima Kurashiki Okayama
TEL
086-462-1111
Homepage URL
yamayou@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school, Breast Thyroid Surgery
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 24 | 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
| 2014 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016703
