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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000165
Receipt No. R000000236
Scientific Title Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Date of disclosure of the study information 2005/09/12
Last modified on 2005/09/12

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Basic information
Public title Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Acronym Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Scientific Title Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Scientific Title:Acronym Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of preoperative chemotherapy using Docetaxle and trastuzumab in stage IIIB and IIIC breast cancer with HER2 over expression.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 1) efficacy 2) safety
Key secondary outcomes 1) histologic effect 2) overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preoperative chemotherapy of docetaxel and trastuzumab
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 Female
Key inclusion criteria 1)Histologically proven breast cancer with stage IIIB and IIIC 2)HER2 over expression detected by IHC (score3+ and score2+ with HER2 genetic over expression detected by FISH) 3) PS:0-1 4) Aged 20 to 75 years 5)Previously untreated for breast cancer with chemotherapy, radiotherapy, endocrinotherapy, or immunotherapy 6)Bidimentionally measurable disease by CT scan or MRI 7) Sufficient organ function 8)Written informed concent
Key exclusion criteria 1)Drug allergy 2)Distant metastasis 3)Bilateral breast cancer 4)male 5)Double cancer 6)Uncontrollable complication 7)Heart disease 8) LVEF<50% by echocardiogram 9)Cardiac performance class II, III and IV by New York Heart Association Functional Classification 10)Sever infection 11)Motor paralysis or neuropathy 12)Pleural or subpericardial effusion 13)Pregnancy 14)Edema with grade G2 or more 15)Interstitial pneumonia or pulmonary fibrosis 16)Hypersensitivity for polysorubate 17) Positive HBs antigen 18)Psychological disease 19)Others
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroji Iwata, M.D.
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroji Iwata, M.D.
Organization Aichi Cancer Center
Division name Department of Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL 052-762-6111
Homepage URL
Email hiwata@aichi-cc.jp

Sponsor
Institute Toukai Breast Cancer Clinical Reserch Group
Institute
Department

Funding Source
Organization non
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
2005 Year 09 Month 12 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
Date of protocol fixation
2004 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 08 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2007 Year 10 Month 01 Day
Date trial data considered complete
2007 Year 10 Month 01 Day
Date analysis concluded
2007 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2005 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000236

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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