Unique ID issued by UMIN | UMIN000006158 |
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Receipt number | R000007078 |
Scientific Title | Evaluation of efficacy and safety of Abraxane for metastatic breast cancer |
Date of disclosure of the study information | 2011/08/15 |
Last modified on | 2018/08/17 09:23:30 |
Evaluation of efficacy and safety of Abraxane for metastatic breast cancer
Abraxane Phase II study for metastatic breast cancer
Evaluation of efficacy and safety of Abraxane for metastatic breast cancer
Abraxane Phase II study for metastatic breast cancer
Japan |
Metastatic breast cancer
Breast surgery |
Malignancy
NO
Evaluation of the effficacy and safety of Abraxane as 1st/2nd line therapy for metastatic breast cancer.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Safety
Response rate
Progression-free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Abraxane: 260mg/m2, iv, day 1
Every 3 weeks
20 | years-old | <= |
Not applicable |
Female
1. Histologically confirmed
metastatic breast cancer.
2. Age are more than 19 years old
3. within withiin 1 prior treatment for metastatic breast cancer.
4. With evaluable leasion
5. Performance statu is 0,1,2.
6. Required baseline laboratory data. (within 14 days of registration)
WBC > 4,000 /mm3 or Neu > 2,000/mm3
PLT > 100,000 /mm3
Hb > 9.0 g/dL
ALT and AST < ULNx2.5
ALT and AST < ULNx2.5
T-Bil < 1.5mg/dL
serum creatine < 1.5mg/dL
9. Expected survival time: more than 3 months.
10.Written informed- consent
1. With history of hypersensitivity reaction for paclitaxel and/or Albumin. 2. With severe complications.
3. Pregnant or nursing women.
4. With widespread liver metastases or with dyspnea in pulmonary lymphangitis.
5. With severe complications.
6. With brain metastasis.
7. with uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease.
8. With pulmonary fibrosis or pneumonitis.
9. With dyspnea at rest.
10. With pleural effusion, ascites, pericardial effusion.
11. Doctor's decision not to be registered to this study.
35
1st name | |
Middle name | |
Last name | Hirotaka Iwase |
Kumamoto university, Graduate School ofMedical Sciences
Department of Breast and Endocrine surgery
1-1-1 Honjo, Kumamoto
096-373-5521
1st name | |
Middle name | |
Last name | Yutaka Yamamoto |
Kumamoto university, Graduate School ofMedical Sciences
Department of Breast and Endocrine surgery
1-1-1 Honjo, Kumamoto
096-373-5521
Kumamoto Breast Cooperative Group
none
Self funding
NO
2011 | Year | 08 | Month | 15 | Day |
Unpublished
No longer recruiting
2011 | Year | 02 | Month | 07 | Day |
2011 | Year | 04 | Month | 01 | Day |
2015 | Year | 05 | Month | 31 | Day |
2015 | Year | 05 | Month | 31 | Day |
2011 | Year | 08 | Month | 12 | Day |
2018 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007078
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