Unique ID issued by UMIN | C000000263 |
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Receipt number | R000000331 |
Scientific Title | First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study |
Date of disclosure of the study information | 2005/10/15 |
Last modified on | 2010/04/15 23:20:54 |
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Her-mono study)
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study
First-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC)- a phase 2 study(Her-mono study)
Japan |
breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
The purpose of this study is to evaluate the efficacy and safety of first-line Trastuzumab monotherapy in patients with HER2-positive metastatic breast cancer(MBC).
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
response rate
Progression-free survival(PFS)
Overall survival(OS)
adverse event(AE)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
chemotherapy(Trastuzumab)
20 | years-old | <= |
75 | years-old | >= |
Female
Histologically confirmed mastocarcinoma
No previous treatment except for endocrine therapy
HER2 status of primary or metastatic tumour was assessed positive
Measurable or evaluable lesion
ECOG performance status 0,1 or 2
Age: 20-75 years old
Ample organ function
Signed informed consent
Documented history of serious hypersensitivity reaction on the medical drugs
Severe complication
Fever, suspicious of infection
Severe pleural fluid and pericardial effusion
Symptomatic brain metastasis
Active double cancer
Interstitial pneumonia or pulmonary fibrosis
Neuropathy
Grade 2,3 or 4 edema
Pregnant or lactating women
Doctor' s decision for exclusion
35
1st name | |
Middle name | |
Last name | Norikazu Masuda |
Osaka National Hospital
Department of Surgery(Breast Oncology)
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
06-6942-1331
1st name | |
Middle name | |
Last name |
H/D study group on Breast Cancer
Executive Office
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
06-6942-1331
H/D study group on Breast Cancer
H/D study group on Breast Cancer
Self funding
NO
2005 | Year | 10 | Month | 15 | Day |
Unpublished
Completed
2002 | Year | 12 | Month | 10 | Day |
2003 | Year | 02 | Month | 01 | Day |
2008 | Year | 01 | Month | 01 | Day |
2005 | Year | 10 | Month | 15 | Day |
2010 | Year | 04 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000331
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