UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000413 |
|---|---|
| Receipt number | R000000502 |
| Scientific Title | Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer |
| Date of disclosure of the study information | 2006/05/01 |
| Last modified on | 2009/05/30 13:31:01 |
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Basic information
Public title
Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer
Acronym
Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer (GENESIS-BC-01)
Scientific Title
Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer
Scientific Title:Acronym
Validation of genetic diagnosis to predict sensitivity in primary systemic chemotherapy with paclitaxel in women with breast cancer (GENESIS-BC-01)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Validate to predict pathological response by sensitivity test using genetic diagnosis in primary systemic chemotherapy with paclitaxel in patients with breast cancer. The validity is defined as accuracy of prediction system for sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Accuracy of prediction system of sensitivity: Elucidate a population of patients who are sensitive to paclitaxel by performing quantitative RT-PCR on about 50 genes before administration of paclitaxel. Evaluate pathological response by paclitaxel in patients who are diagnosed as positive sensitivity and compare those in patients who do not receive sensitivity testing. Improvement of pathological response rate is judged as high accuracy of prediction system for sensitivity
Key secondary outcomes
Examine the influence of genetic diagnosis on pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant-metastasis free survival, disease free survival and overall survival.
Examine the association between genetic polymorphism and adverse events by chemotherapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Arm A: Patients do not utilize genetic diagnosis for sensitivity to paclitaxel and receive primary chemotherapy with paclitaxel (Patients are randomized to arm A or B with ratio 1 to 4.)
Interventions/Control_2
Arm B: Patients utilize genetic diagnosis for sensitivity to paclitaxel. Patients who are diagnosed as sensitive to paclitaxel receive primary chemotherapy with paclitaxel. Pateints who are diagnosed as insensitive to paclitaxel receive primary chemotherapy with FEC100.(Patients are randomized to arm A or B with ratio 1 to 4.)
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
| Not applicable |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Histologically confirmed breast cancer with tumor size 3cm and more in stageIIA-StageIIIB.
Operable case.
Age below 70.
PS 0 or 1.
Life expectancy 6 months and more.
WBC:4,000/micro L and more or ANC:2,000/micro L and more.
Platelet:100,000/micro L and more.
Hemoglobin:9g/dl and more.
AST(GOT),ALT(GPT):twice of an upper limit of normal value and less.
Serum total bilirubin:1.5 mg/dl and less.
BUN,Creatinine:an upper limit of normal value and less.
ECG within normal limit.
Given written consent.
Key exclusion criteria
Non invasive or microinvasive breast cancer.
Stage IIIC, IV.
Inflammatory breast caner.
Male breast cancer.
Previously treated with chemotherapy, hormone therapy or radiotherapy.
Active double cancer.
Serious complication (infection, cardiac disease, pulmonary fibrosis interstitial pneumonitis, bleeding).
Hepatitis type B and its carrier.
Uncontrolled diabetes.
Heavy history of drug allergy.
History of allergic reaction to drugs using the vehicle Cremophor.
Pregnant, nursing or willing to be pregnant.
Inadequate to entry judged by investigators.
Target sample size
109
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ito |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Medical Oncology, Division of Breast Cancer
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daigo Syouji |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Medical Oncology
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
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
| 2006 | Year | 05 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2005 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 05 | Month | 01 | Day |
Last modified on
| 2009 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000502
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