Unique ID issued by UMIN | UMIN000004741 |
---|---|
Receipt number | R000005386 |
Scientific Title | A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer |
Date of disclosure of the study information | 2010/12/17 |
Last modified on | 2018/07/13 10:22:59 |
A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate effectiveness and safety of weekly Paclitaxel plus Gemcitabine combination therapy in patients with 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 |
Paclitaxel 80mg/m2,iv, Day1/8/15
Gemcitabine 1200mg/m2,iv,Day1/8
Every28 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 don't have recieved Taxans 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 6 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
35
1st name | |
Middle name | |
Last name | Shinya Tokunaga |
Osaka City General Hospital
Department of Medical Oncology
534-0021 2-13-22,miyakojima-hondori,miyakojima-ku,Osaka
06-6929-1221
s-tokunaga@med.osakacity-hp.or.jp
1st name | |
Middle name | |
Last name | Norikazu Masuda |
Kinki Multidisciplinary Breast Oncology Group
Executive office
540-0006 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
2010 | Year | 12 | Month | 17 | Day |
Unpublished
Completed
2010 | Year | 09 | Month | 10 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2013 | Year | 12 | Month | 31 | Day |
2010 | Year | 12 | Month | 17 | Day |
2018 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005386