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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014479
Receipt No. R000016822
Scientific Title Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy
Date of disclosure of the study information 2014/07/04
Last modified on 2014/07/04

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Basic information
Public title Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy
Acronym Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy
Scientific Title Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy
Scientific Title:Acronym Development of novel predictive biomarkers for breast cancer with neoadjuvant chemotherapy
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identify predictive biomarkers for breast cancer treated with neoadjuvant chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To compare RNA expressions between breast cancers with complete response to neoadjuvant chemotherapy and tumors with non-complete responses for each subtype
Key secondary outcomes To compare RNA expressions in each breast cancer subtype

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
75 years-old >
Gender Female
Key inclusion criteria A patient planning to undergo breast biopsy with written informed consent because breast cancer was clinically suspected
1. Lesion over 2 cm tumor size
2. Age >= 20 and < 75
3. Performance status 0-1
4. Normal cardiac function (EF>55% by ultrasound)
5. Normal liver functions (AST/ALT <= upper limit of normal * 2.5 and T.bil <= 2.0mg/dl)
6. Normal kidney function(Cr <= 1.5mg/dl)
7. Without distant metastatic lesions, basically, except the for stage IV without lethal metastases, and scheduled to undergo local control surgery after chemotherapy

Patients with neoadjuvant chemotherapy are as follows:
(1) Fine needle aspiration cytology for axillary lymph nodes proven to be positive for cancer cells or axillary lymph node positivity is highly suspected clinically
(2) Breast conserving operation is expected with neoadjuvant chemotherapy, regardless of nodal status
(3) Triple negative or HER 2 type breast cancer according to core needle biopsy results, regardless of nodal status
(4) Judged to have an indication for PST by the doctor in charge
Key exclusion criteria 1. Ductal carcinoma in situ
2. Any past history of malignant disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsue Saito
Organization Juntendo University
Division name Breast oncology
Zip code
Address 3-1-3, Hongo Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email mitsue@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hyonmi Sai
Organization Juntendo University
Division name Breast Oncology
Zip code
Address 3-1-3, Hongo Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email shyonmi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor RIKEN
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 07 Month 04 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 Enrolling by invitation
Date of protocol fixation
2013 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective study to identify predictive biomarkers for breast cancer treated with neoadjuvant chemotherapy

Management information
Registered date
2014 Year 07 Month 04 Day
Last modified on
2014 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016822

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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