Unique ID issued by UMIN | C000000165 |
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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 |
Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Study of Docetaxle and trastuzumab as preoperative chemotherapy for advanced-stage breast cancer with HER2 over expression
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
To evaluate the safety and efficacy of preoperative chemotherapy using Docetaxle and trastuzumab in stage IIIB and IIIC breast cancer with HER2 over expression.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
1) efficacy 2) safety
1) histologic effect 2) overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Preoperative chemotherapy of docetaxel and trastuzumab
20 | years-old | <= |
75 | years-old | >= |
Female
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
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
40
1st name | |
Middle name | |
Last name | Hiroji Iwata, M.D. |
Aichi Cancer Center
Department of Breast Oncology
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
052-762-6111
1st name | |
Middle name | |
Last name | Hiroji Iwata, M.D. |
Aichi Cancer Center
Department of Breast Oncology
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
052-762-6111
hiwata@aichi-cc.jp
Toukai Breast Cancer Clinical Reserch Group
non
Self funding
NO
2005 | Year | 09 | Month | 12 | Day |
Unpublished
2004 | Year | 03 | Month | 01 | Day |
2004 | Year | 08 | Month | 01 | Day |
2007 | Year | 04 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2007 | Year | 10 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2005 | Year | 09 | Month | 12 | Day |
2005 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000236
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