Unique ID issued by UMIN | UMIN000010761 |
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Receipt number | R000012559 |
Scientific Title | Prospective study of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC06) |
Date of disclosure of the study information | 2013/05/21 |
Last modified on | 2019/01/08 18:37:59 |
Prospective study of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC06)
Prospective study of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC06)
Prospective study of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC06)
Prospective study of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer (KSCOG-BC06)
Japan |
HER2 positive metastatic breast cancer
Breast surgery |
Malignancy
NO
To evaluate efficacy and safety of Eribulin plus Trastuzumab in patients with HER-2 positive metastatic breast cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate,Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of eribulin with a dose of 1.4 mg/m2 for days1 and 8. Administration of Trastuzumab every 3 weeks with a starting dose of 8 mg/kg followed by 6 mg/kg as the second and subsequent doses.
20 | years-old | <= |
80 | years-old | > |
Female
1.Histological and/or cytological confirmed breast cancer
2.Metastatic breast cancer
3.HER2 positive (3+ staining by IHC or HER2 gene amplification by FISH) confirmed in the invasive component of the primary or metastatic lesion
4.age:>=20 and <80
5.Performanse Status:0-2(ECOG)
6.The below criteria are met about prior therapy
(1)chemotherapy:more than 7 days passed after chemotherapy
(2)hormonal therapy:more than 7 days passed after hormonal therapy
(3)radiation:more than 14 days passed after radiation
7.Expected survival longer than 3 months
8.Sufficient function of important organs within 7 days prior to entry
(1)WBC between 3,000 and 12,000
(2)Granulocyte count 1,500 or over
(3)Platelet count 100,000 or over
(4)Total bilirubin <= the upper limit of normal range in each institute
(5)AST(GOT)<= 2.5 times of the upper limit of normal range in each institute
(6)ALT(GPT))<= 2.5 times of the upper limit of normal range in each institute
(7)Serum creatinine <= the upper limit of normal range in each institute
(8)Left ventricle ejection fraction 50% or over by cardiac sonography or MUGA scan
(9)Ccr:>=50 ml/min
9.Written informed consent to participate
1.With contraindicate Eribulin and Trastuzumab
2.With active double cancer
3.With uncontrolled diabetes
4.Heart failure with clinically problem
5.Symptomatic brain metastasis
6.With mental disorder which become problem on clinical practice
7.With uncontrolled hypertension
8.Physician judged improper to entry this trial
30
1st name | |
Middle name | |
Last name | Toh Uhi |
Kurume University School of Medicine
Department of Surgery
67 Asahi-machi,Kurume city,Fukuoka
0942-317566
utoh@med.kurume-u.ac.jp
1st name | |
Middle name | |
Last name | Toh Uhi |
Kurume University School of Medicine
Department of Surgery
67 Asahi-machi
0942-317612
utoh@med.kurume-u.ac.jp
Kurume University School of Medicine
Department of Surgery
Kurume University School of Medicine
Department of Surgery
Other
NO
2013 | Year | 05 | Month | 21 | Day |
Unpublished
Terminated
2012 | Year | 12 | Month | 06 | Day |
2013 | Year | 02 | Month | 01 | Day |
2016 | Year | 01 | Month | 01 | Day |
2013 | Year | 05 | Month | 20 | Day |
2019 | Year | 01 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012559
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