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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000413
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000502

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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