Unique ID issued by UMIN | UMIN000008839 |
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Receipt number | R000010382 |
Scientific Title | Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2014/04/11 14:56:37 |
Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane
EVA study
Randomized phase II study of eribulin versus nab-paclitaxel in patients with relapsed HER2-negative breast cancer previously treated with anthracycline and peri-operative taxane
EVA study
Japan |
Breast Cancer relapsed after surgery
Hematology and clinical oncology |
Malignancy
NO
To investigate the efficacy of eribulin in comparison of nab-paclitaxel
Efficacy
Exploratory
Pragmatic
Phase II
Progression-free survival
Overall response rate, overall survival, and safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
Central registration
2
Treatment
Medicine |
nab-paclitaxel
eribulin
20 | years-old | <= |
Not applicable |
Female
1) histologically or cytologically proven breast cancer
2) relapsed after surgery
3) HER2 negative
4) patient with assessable lesion
5) prior peri-operative taxane
6) prior anthracycline
7) first- or second-line
8) appropriate period from prior therapy
21 days from chemotherapy
7 days from hormone therapy
14 days from radiotherapy
28 days from major surgery
14 days from minor surgery
9) PS (ECOG) 0-1
10) adequate organ function
neutrophil>=1,500/mm3
platelet>=100,000/mm3
hemoglobin>=9.0 g/dL
AST (GOT) <=100 IU/L (<=150 IU/L if liver metastases)
ALT (GPT) <=100 IU/L (<=150 IU/L if liver metastases)
T-Bil<=1.5 mg/dL
serum Cr<=1.5 mg/dL
SpO2>=94% (ambient air)
11) 20 years or older
12) Written informed consent
13) life expectancy>=90 days
1) prior eribulin and/or nab-paclitaxel
2) taxane for metastatic disease
3) <6monthd from last taxane administration
4) Effusions (pleural, pericardial effusion, ascites) requiring treatment
5) brain metastasis requiring treatment
6) >=grade 2 peripheral sensory neuropathy (CTCAE ver4.0)
7) clinically abnormal ECG
8) systemic infection
9) severe diabetes mellitus
10) interstitial pneumonia/pulmonary fibrosis apparent on chest Xp
11) active double cancer
12) severe psychosis
13) systemic corticosteroid
14) severe drug allergy
15) hypersensitivity for paclitaxel and/or albumin
16) positive HBs antigen
17) pregnant or lactating woman
18) other causes judged ineligible by attending physician
140
1st name | |
Middle name | |
Last name | Yoichi Naito |
National Cancer Center Hospital East
Department ofBreast and Medical Oncology
6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
04-7133-1111
1st name | |
Middle name | |
Last name | Shinichiro Nakamura |
West Japan Oncology Group
WJOG datacenter
Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN
06-6633-7400
datacenter@wjog.jp
West Japan Oncology Group
none
Self funding
NO
2012 | Year | 10 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 08 | Month | 18 | Day |
2012 | Year | 10 | Month | 09 | Day |
2012 | Year | 09 | Month | 03 | Day |
2014 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010382
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