UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002834 |
|---|---|
| Receipt number | 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 10:32:19 |
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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 ≥ 60% is needed (estimated by echocardiography)
4. Hepatic: AST & ALT ≤*2.5 upper normal limit, Total bilirubin ≤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 ≥1.5 cm (preferably ≥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
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
Sponsor or person
Institute
Department of Breast and Endocrine Surjery, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003434
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