Unique ID issued by UMIN | UMIN000009296 |
---|---|
Receipt number | R000010915 |
Scientific Title | Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer. |
Date of disclosure of the study information | 2012/11/09 |
Last modified on | 2016/12/06 19:13:10 |
Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Eriblin with Trastuzumab for HER2 positive MBC.
Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Eriblin with Trastuzumab for HER2 positive MBC.
Japan |
HER2 positive metastatic breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate the efiicacy and safety of combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Efficacy
Confirmatory
Explanatory
Phase II
Response rate
Progression free survival, Overall survival, Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination of Eribulin with Trastuzumab.
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1.Histologically confirmed invasive breast cancer in biopsy specimens obtained from the tumor.
2.Presense of overexpression of HER2 in the tumor examined.
3.At least one measurable metastatic lesion other than the breast tumor and axillary lymph nodes detected by CT or MRI before primary registration.
4.ECOG performance status (PS) 0,1,2
5.No surgery, chemotherapy or radiotherapy for any other malignancies within the previous 3 weeks.
6.Adequate organ functions.
7.Availability of written informed consent.
1. Simultaneous or metachronous (within 5 years) double cancers.
2.Pregnant or breast-feeding women.
3. Psychiatric diseases.
4. Systemic and continuous steroid treatment.
5. with symptomatic brain metastasis
6. Uncontrolled hypertension.
7. Uncontrolled diabetes mellitus or the disease being treated by continuous insulin administration.
30
1st name | |
Middle name | |
Last name | Tadahiko Shien |
Okayama University Hospital
Breast and Endocrine Surgery
2-5-1 Shikata-cho, Kita-Ku, Okayama, Japan
086-235-7265
tshien@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Tadahiko Shien |
Setouchi Breast Project
Clinical trial committee
2-5-1Shikata-cho, Kita-ku, Okayama
086-235-7265
info@setouchi-bp.com
Setouchi Breast Project
Setouchi Breast Project
Other
NO
2012 | Year | 11 | Month | 09 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 25 | Day |
2012 | Year | 09 | Month | 25 | Day |
2012 | Year | 11 | Month | 09 | Day |
2016 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010915
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |