Unique ID issued by UMIN | UMIN000021585 |
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Receipt number | R000024896 |
Scientific Title | A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer |
Date of disclosure of the study information | 2016/03/23 |
Last modified on | 2021/03/27 14:46:45 |
A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
SBCCSG-36
A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
SBCCSG-36
Japan |
First-Line therapy for metastatic HER2-positive breast cancer.
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate the usefulness of eribulin in combination with trastuzumab and pertuzumab as first line therapy for patients with metastatic HER2-positive breast cancer.
Safety,Efficacy
Exploratory
Phase II
time to chemotherapy treatment failure of response rate
time to chemotherapy treatment failure, progression free survival, response rate, overall survival, safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Administration of eribulin,trastuzumab, and pertuzumab every three weeks until disease progression or occurring adverse events difficult to continue.
18 | years-old | <= |
Not applicable |
Female
1.Histologically confirmed primary breast cancer
2.Age of 18 years and expected survival is more than 6months
3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH)
4.First line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer
5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases)
6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone
7.Adequate organ function shown in physical examinations within 14 days prior to enrollment
Neutrophil count >=1500/mm3
Platelet count >=75,000/mm3
Hemoglobin >=9.0g/dL
Total serum bilirubin <=2.0mg/dL
AST and ALT <100IU/L
Serum creatinine <=1.5mg/dL
8.No clinical electrocardiographic abnormality
9.Echocardiographic ejection fraction >=55%
10.Subjects who have submitted written informed consent for study entry
1.Active infection or fever at risk of infection
2.History of serious drug allergies
3.Spontanous serious renal damage or liver dysfunction(jaundice)
4.Large pleural effusion or ascites requiring repeat drainage
5.Systemic administration of steroid drug
6.Pregnant females or females of child-bearing potential
7.Concurrent active other malignancy
8.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ
9.Clinically important mental disorder or history of central nervous system damage
10.Clinically significant central nervous system metastases
11.Concurrent enrollment of other clinical trial
12.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate
13.HBs antigen positive
14.Not suitable for participation with any other reasons
(including rapid progression disease, life threatening status if not successfully treated)
16
1st name | Kenichi |
Middle name | |
Last name | Inoue |
Saitama Cancer Center
Division of Breast Oncology
3620806
780, Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
048-722-1111
ino@cancer-c.pref.saitama.jp
1st name | Jun |
Middle name | |
Last name | Ninomiya |
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Secretariat Division (Ninomiya hospital)
330-0843
491-6 shineicho, soka-shi, saitama-shi
048-941-2223
http://www.sbccsg.org/
jninomiya@grape.plala.or.jp
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Self funding
Japan
Saitama Cancer Center
780 komura ina kitaadachi Saitama Japan
0487221111
sccctmo01@cancer-c.pref.saitama.jp
NO
2016 | Year | 03 | Month | 23 | Day |
Unpublished
No longer recruiting
2016 | Year | 02 | Month | 15 | Day |
2016 | Year | 03 | Month | 24 | Day |
2016 | Year | 03 | Month | 23 | Day |
2021 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024896
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