Unique ID issued by UMIN | UMIN000005982 |
---|---|
Receipt number | R000007077 |
Scientific Title | Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer |
Date of disclosure of the study information | 2011/07/15 |
Last modified on | 2012/01/17 09:57:22 |
Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Phase II study of weekly Nab-paclitaxel for Metastatic Breast Cancer
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To investigate the efficacy and safety of weekly Nab-paclitaxel for metastatic breast cancer
Efficacy
Response rate
Adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Nab-paclitaxel is 100 mg/m2 administered weekly intravenously over 30 minutes
20 | years-old | <= |
Not applicable |
Female
1) Histologically confirmed primary breast cancer
2) Clinically confirmed metastatic breast cancer
3) With measurable lesion
4) Received no previous chemotherapy, or only two regimen
5) Age >= 20 years
6) ECOG performance status of 0 or 1
7) Required baseline laboratory parameters (within 14 days before registration)
Hb >= 9.0g/dL
WBC >= 4,000/mm3
Neu >= 2,000/mm3
Plt >= 10.0x104/mm3
T-Bil <= 1.5mg/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Cre <= 1.5mg/dL
8) A life expectancy of more than 90 days
9) Written informed consent
1) Allergy of nab-paclitaxel, albumin or paclitaxel
2) Serious complication
3) Synchronous or metachronous (within 5 years) double cancers
4) Abnormal ECG
5) Congestive heart failure, coronary artery diseases, uncontrollable arrhythmia or past history of myocardial infarction or angina pectoris within 6 months
6) Relapsed within 12 months (or during its treatment) after taxane-based neoadjuvant and adjuvant chemotherapy. Resistant to taxane-based neoadjuvant chemotherapy
7) Fully recovered from surgical within 4 weeks before registration
8) Received radiotherapy or neoadjuvant and adjuvant chemotherapy within 3 weeks before registration
9) Received endocrine therapy within 2 weeks before registration
10) Received ratiotherapy for more than 30% of hematopoietic bone marrow
11) Peripheral neuropathy grade 2 or greater
12) Active infection
13) Symptomatic brain metastasis
14) Un-controlled pleural effusion and ascites
15) Long-term corticosteroid therapy
16) Mental disorder
17) Pregnancy, breast feeding or wish of future bearing
18) Patients considered inappropriate by the study investigator
40
1st name | |
Middle name | |
Last name | Shoji Oura |
Wakayama Medical University
Department of Thoracic and Cardiovascular Surgery
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
1st name | |
Middle name | |
Last name |
Wakayama Medical University
Department of Thoracic and Cardiovascular Surgery
811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
Wakayama Medical University
None
Self funding
Minami Wakayama Medical Center
Hashimoto Municipal Hospital
NO
2011 | Year | 07 | Month | 15 | Day |
Unpublished
Open public recruiting
2011 | Year | 06 | Month | 17 | Day |
2011 | Year | 07 | Month | 01 | Day |
2013 | Year | 12 | Month | 01 | Day |
2011 | Year | 07 | Month | 15 | Day |
2012 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007077