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 2015/04/30 20:15:57

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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



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 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


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

Value
https://center6.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