UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013815
Receipt No. 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 2015/04/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
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
Email 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
Email syueda@saitama-med.ac.jp

Sponsor
Institute Saitama International Medical Center
Institute
Department

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
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 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
2015 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.