UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013815 |
|---|---|
| Receipt number | R000016123 |
| Scientific Title | Clinical study: Early prediction of tumor response using imaging and molecular biomarkers of hormone sensitive breast cancer in neoadjuvant hormonal therapy setting |
| Date of disclosure of the study information | 2014/04/25 |
| Last modified on | 2024/12/20 15:58:36 |
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Basic information
Public title
Clinical study: Early prediction of tumor response using imaging and molecular biomarkers of hormone sensitive breast cancer in neoadjuvant hormonal therapy setting
Acronym
Imaging and molecular biomarker study of hormone sensitive breast cancer in neoadjuvant hormonal therapy setting
Scientific Title
Clinical study: Early prediction of tumor response using imaging and molecular biomarkers of hormone sensitive breast cancer in neoadjuvant hormonal therapy setting
Scientific Title:Acronym
Imaging and molecular biomarker study of hormone sensitive breast cancer in neoadjuvant hormonal therapy setting
Region
| Japan |
Condition
Condition
Hormonal sensitive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether imaging and molecular biomarkers can predict early tumor clinicopathological outcome in patients with hormonal sensitive breast cancer in neoadjuvant hormonal therapy setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical response rate
Key secondary outcomes
SUV change rate by PET,Labeling index by Ki-67,Hb change rate by DOSI,DFS,OS
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Letrozole 2.5mg/day daily p.o.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Clinical tumor size 3cm or more
2. cN0 or cN1
3. M0 or M1
4. ERand/or PgR positive and HER2 negative
5. Normal range of routine lab data
6. Patients whom doctors in charge consider benefit of hormane therapy
7. Patients who have accept study participation under document
Key exclusion criteria
Patients who have already underwent chemotherapy or hormonal therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama International Medical Center
Division name
Department of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
81-42-984-4670
syueda@saitma-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIchiko Sugiyama |
Organization
Saitama International Medical Center
Division name
Department of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
81-42-984-4670
Homepage URL
syueda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Breast Oncology
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 | 04 | Month | 25 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016123
