UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014479 |
|---|---|
| Receipt number | 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 14:09:24 |
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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
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
shyonmi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016822
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
