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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002834
Receipt No. R000003434
Scientific Title Evaluation Study for its Clinical Utility of Gene Prognostic Signature MammaPrint for Early-Breast Cancer
Date of disclosure of the study information 2009/12/03
Last modified on 2009/12/03

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Basic information
Public title Evaluation Study for its Clinical Utility of Gene Prognostic
Signature MammaPrint for Early-Breast Cancer
Acronym Utility of Gene Prognostic
Signature MammaPrint for Early-Breast Cancer
Scientific Title Evaluation Study for its Clinical Utility of Gene Prognostic
Signature MammaPrint for Early-Breast Cancer
Scientific Title:Acronym Utility of Gene Prognostic
Signature MammaPrint for Early-Breast Cancer
Region
Japan

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

Objectives
Narrative objectives1 MammaPrint will be performed for the patients who fulfill the MammaPrint applicable standard and who approve for participation in the clinical trial.
(1)To compare the MammaPrint risk assessment with conventionally used risk assessments determined by standard staging and IHC analysis (e.g. Adjuvant! Online, St. Gallen or local guidelines), and to assess the proportion of patients in the two MammaPrint risk categories in Japanese populations.
(2)To examine MammaPrint's prognostic power is to complement/exceed conventional method of IHC analysis.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation to decide breast cancer adjuvant therapy and treatment by applying MammaPrint to each patient to see if prognosis by gene expression profiling.
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 * For patients identified as low risk by both MammaPrint and conventional method, no adjuvant chemotherapy will be applied.
* For patients identified differently by MammaPrint and conventional method, both risk categories are considered, and adjuvant chemotherapy will be applied.
* For HR positive patients, hormonal therapy will be applied. Premenopausal pts: LH-RH for 2 yrs + TAM for 5 yrs. Menopausal pts: Aromatase inhibitor for more than 5 yrs.)
For patients with HER2+++ or FISH positive and applied for FEC treatment, adjuvant therapy by Herceptin will be given for 1 year.
All patients will be observed for distant metastasis and/or recurrence by every 3 months for 2 years after surgery, then by every 6 months after 2 years after surgery up until for 10 years.
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 Male and Female
Key inclusion criteria 1. Age between 20 to 75
2. ECOG performance status 0-1
3. Cardiac: Ejection fraction &#8805; 60% is needed (estimated by echocardiography)
4. Hepatic: AST & ALT &#8804;*2.5 upper normal limit, Total bilirubin &#8804;2.0 mg/dL
5. Invasive breast cancer, Stage I & II, by core needle biopsy
6. Lymph node negative patient (N0) by palpation and by ultrasound
7. Tumor size &#8805;1.5 cm (preferably &#8805;2.0 cm)
8. Able to collect fresh samples (No formalin fixation)
9. Able and willing to give valid written informed consent
10. No complication
Key exclusion criteria 1. Developed malignancy except carcinoma in situ
2. Received Neo-adjuvant therapy treatment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsue Saito
Organization Juntendo University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Department of Breast and Endocrine Surjery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Breast and Endocrine Surjery, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization JUntendo University School of Medicine
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
2009 Year 12 Month 03 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
2009 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2021 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003434

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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