Unique ID issued by UMIN | UMIN000004839 |
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Receipt number | R000005764 |
Scientific Title | A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer |
Date of disclosure of the study information | 2011/01/07 |
Last modified on | 2018/07/13 10:28:56 |
A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
A Phase II study of vinorelbine plus Gemcitabine Combination Chemotherapy in Patients with taxans refractory advanced or metastatic Breast Cancer
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate effectiveness and safety of vinorelbine plus Gemcitabine combination therapy in patients with taxans refractory advanced or metastatic Breast Cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Progression free survival,
Overall survival,
Time to treatment failure,
Safety profiles
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
vinorelbine 25mg/m2,IV, Day1,8
Gemcitabine 1200mg/m2,IV,Day1,8
Every21 days
20 | years-old | <= |
75 | years-old | >= |
Female
1)Patient who confirmed histologically HER2 negative as Metastatic breast cancer
2)ECOG PS 0-1
3)Mesurable disease as per RECIST criteria
4)Patients who have been taxans refractory and don't have recieved vinorelbine and Gemcitabine
5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration
leukocyte>=3000mm3 or neutrophil>=1500mm3
hemoglobin>=9.0g/dL
platelet count>=100,000/mm3
AST,ALT<=100IU/L
total bilirubin=<1.5mg/dL
serum creatinine<=1.5mg/dL
6)Expected survival time : more than 3 months
7)Clinically no problem with an electrocardiogram
8) Given written informed concent
1) Pulmonary fibrosis or pneumonia
2) body cavity fluid whichi needs to be treated
3)Symptomatic brain metastasis
4) Active double cancer
5) The diabetes that is impossible of control and high blood pressure case
6)HBs antigen positive
7)Heart diseases with the following items
History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months
Congestive heart failure
Arrhythmia which needed to be treated
8)Apparently/possibly during pregnancy or lactation expectant
9) Serious drug allergy
10) Judged by the investigator to be unfit to be enrolled into the study
42
1st name | |
Middle name | |
Last name | Yukihiro Nishida |
Nissay Hospital
Department of Breast Surgery
6-3-8,tachiuribori,nishi-ku,Osaka
06-6543-3581
nishida.yukihiro@nissay-hp.or.jp
1st name | |
Middle name | |
Last name | Norikazu Masuda |
Kinki Multidisciplinary Breast Oncology Group
Executive office
2-1-14,hoenzaka,chuo-ku,Osaka
06-6942-1331
nmasuda@alpha.ocn.ne.jp
Kinki Multidisciplinary Breast Oncology Group
Sakai Clinical Research Supporting Center(SCRSC)
Non profit foundation
Japan
NO
2011 | Year | 01 | Month | 07 | Day |
Published
Completed
2010 | Year | 09 | Month | 10 | Day |
2010 | Year | 12 | Month | 01 | Day |
2011 | Year | 01 | Month | 07 | Day |
2018 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005764
Research Plan | |
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