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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014351
Receipt No. 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

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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
Email 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
Email yamayou@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016703

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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