Unique ID issued by UMIN | UMIN000011258 |
---|---|
Receipt number | R000013166 |
Scientific Title | Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer |
Date of disclosure of the study information | 2013/09/01 |
Last modified on | 2013/07/22 16:13:50 |
Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer
KBCOG13
Clinical trial of the efficacy of new S-1 schedule (administered 14days followed by 7 days rest) for metastatic or recurrent breast cancer
KBCOG13
Japan |
brest cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate the safety and efficacy of S-1(administered day1-14,followed by 7days rest) for metastatic or recurrence breast cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
Progression free survival
Overall survival
Time to Treatment failure
Response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
S-1 depending on BSA and Ccr is administered orally twice daily after morning and evening meals from day1-14,followed by 7 days rest
20 | years-old | <= |
Not applicable |
Male and Female
1)histologically comfirmed breast cancer
2)metastatic or recurrent breast cancer
3)with at least one evaluable lesion
4)without chemotherapy after decided metastatic or recurrent cancer
5)over 20 years old
6)EOG perfomance status 0-2
7)without previous 5-FU chemotherapy or with interval period of 6months after pre or post operative 5-FU chemothrapy
8)with interval period of 7days after endocrine therapy,or with interval period of 14days after radiation therapy
9)required baseline laboratory parameters
WBC>3000/mm3
neutrophili>1500/mm3
Plt>100,000/mm3
T-Bil<2.0mg/dL
AST,ALT<100IU/L
Ccr>50mL/min
10)without severe heart problem
11)written informed consent was obtained
1)HER2 positive
2)allergy for the medicine of the protocol
3)active double cancer
4)brain metastasis which needs treatment or radiation therapy in an emergency
5)severe liver metastasis or Lung metastasis with dyspnea
6)with pleural effusion,ascitis,ericardial effusion which needs treatment in an emergency
7)active infection
8)interstitial pneumonia
9)HBV antigen positive
10)uncontoroled diabetes mellitus
11)mental disease
12)pregnant or nursing women ,women who like to be
pregnant
13)with doctors decision for exclusion
35
1st name | |
Middle name | |
Last name | Mayuko Miki |
Hyogo Cancer Center
Breast Surgical Oncology
13-70,Kitaoujityou,Akashi-city,Hyogo,Japan,6728558
0789291151
1st name | |
Middle name | |
Last name | Mayuko Miki |
Hyogo Cancet Center
Breast Surgical Oncology
13-70,Kitaoujityou,Akashi-city,Hyogo,Japan,6728558
0789291151
mikimayu@hyogo-cc.jp
Kobe Breast Cancer Oncology Group
KBCOG
Self funding
NO
兵庫県立がんセンター(兵庫県)、甲南病院(兵庫県)、兵庫県立西宮病院(兵庫県)、兵庫県立加古川医療センター(兵庫県)、茶屋町ブレストクリニック(大阪府)、淀川キリスト教病院(大阪府)、大阪府済生会中津病院(大阪府)、こくふブレストクリニック(兵庫県)、神戸大学医学部付属病院(兵庫県)、西神戸医療センター(兵庫県)、いしづか乳腺クリニック(兵庫県)、製鉄記念広畑病院(兵庫県)、甲南加古川病院(兵庫県)、兵庫医科大学(兵庫県)、済生会兵庫県病院(兵庫県)、明石医療センター(兵庫県)、明和病院(兵庫県)、姫路赤十字病院(兵庫県)、愛仁会高槻病院(大阪府)、神鋼病院(兵庫県)、橋本クリニック(兵庫県)、兵庫県立塚口病院(兵庫県)、大山病院(兵庫県)
2013 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2013 | Year | 08 | Month | 24 | Day |
2013 | Year | 09 | Month | 01 | Day |
2018 | Year | 09 | Month | 01 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 10 | Month | 01 | Day |
2013 | Year | 07 | Month | 23 | Day |
2013 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013166
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