UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000165 |
|---|---|
| Receipt number | 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 10:34:16 |
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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
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
hiwata@aichi-cc.jp
Sponsor or person
Institute
Toukai Breast Cancer Clinical Reserch Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000236
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