Unique ID issued by UMIN | UMIN000011049 |
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Receipt number | R000012932 |
Scientific Title | Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer. |
Date of disclosure of the study information | 2013/06/26 |
Last modified on | 2019/02/04 18:15:22 |
Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Safety study of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Japan |
Breast Cancer
Breast surgery |
Malignancy
NO
The purpose of this study was to assess the safety of q3w S-1 in combination with q3w trastuzumab for HER2 positive metastatic breast cancer.
Safety
Exploratory
Pragmatic
Phase II
adverse event
response rate, progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest.
Trastuzumab 6 mg/kg* administered intravenously on day 1 of each 3-week cycle
*:8 mg/kg for the initial dosing
20 | years-old | <= |
Not applicable |
Female
1) Histological and/or cytological confirmed breast cancer
2) HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods
3) ECOG performance status 0-2
4) Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan)
5) Age 20 or over
6) Adequate function of important organs (within 14 days before registaration)
1. WBC: >=4,000/mm3
2. Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T-Bil <= 1.5mg/dL
6. AST <= ULN x 2.5
7. ALT <= ULN x 2.5
8. Creatinin <= 1.5mg/dL
9.Ccr: >=60mL/min
7) Expected survival time: more than 6 months
8) Written informed consent
1) History of hypersensitivity reaction
2) Sever bone marrow suppression, renal dysfunction, liver dysfunction
3) Received S-1
4) Inflammatory breast cancer
5) Active double cancer
6) With widespread liver metastases or with dyspnea in pulmonary lymphangitis
7) With brain metastasis
8) With uncontrollable hypertension, angina, congestive heart failure, myocardial infection within 1 year, arrhythmia, valvular heart disease
9) Insulin therapy or Uncontrolled diabetes
10) With pulmonary fibrosis or pneumonitis
11) With dyspnea at rest
12) With pleural effusion, ascites, pericardial effusion
13) Active infection or potentiality infection
14) Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
15) Judged ineligible based on physicians' decision
20
1st name | |
Middle name | |
Last name | Hirohito Seki |
Kitasato University Kitasato Institute Hospital
Breast Center
Shirokane5-9-1 Minato-ku, Tokyo
1st name | |
Middle name | |
Last name |
Kitasato University Kitasato Institute Hospital
Breast Center
Shirokane5-9-1 Minato-ku, Tokyo
Kitasato University Kitasato Institute Hospital
Kitasato University Kitasato Institute Hospital
Self funding
NO
2013 | Year | 06 | Month | 26 | Day |
Unpublished
Terminated
2013 | Year | 04 | Month | 12 | Day |
2013 | Year | 05 | Month | 21 | Day |
2019 | Year | 02 | Month | 04 | Day |
2013 | Year | 06 | Month | 26 | Day |
2019 | Year | 02 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012932
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