Unique ID issued by UMIN | UMIN000011860 |
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Receipt number | R000013864 |
Scientific Title | Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2015/08/18 14:14:30 |
Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Japan |
breast cancer
Breast surgery |
Malignancy
NO
Non-inferiority of TS-1 to UFT as adjuvant chemotherapy for breast cancer.
(Randomized phaseII trial)
Primary endpoint :
disease-free survival
Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Primary endpoint :
disease-free survival
Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
UFT
TS-1
20 | years-old | <= |
Not applicable |
Female
1) Women with a histopathological diagnosis of invasive breast cancer
2) Curative surgery was performed for an initial diagnosis of stage I to IIIA or stage IIIB breast cancer
3) HER2-negative breast cancer
4) Moderate or high risk of recurrence
5) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, The case that follows the regimen that was established in protocol
6) If postoperative endocrine therapy was being received, The case that follows the regimen that was established in protocol
7) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment.
8) Within one year after surgery and within 6 months after the start of postoperative endocrine therapy
9) Age more than 20 years old , and signed informed consent of the patient for the registration.
10) ECOG performance status is 0 to 1
11) Oral intake is possible
1) Active double cancer
2) Bilateral (synchronous or asynchronous) breast cancer, inflammatory breast cancer
3) A history of previous treatment with oral 5-fluorouracil derivatives for 2 weeks or longer
(Patients who received intravenous 5-fluorouracil can be enrolled.)
4) Serious diarrhea
5) Others, Serious complications
6) Pregnant women, nursing women, or women who want to become pregnant
7) Patients judged to be unsuitable for enrollment in the study by their physicians
380
1st name | |
Middle name | |
Last name | Hidemi Furusawa |
Breastopia Namba Hospital
Breast Surgical oncology
2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan
0985-32-7177
k.abe@breastopia.org
1st name | |
Middle name | |
Last name | Katsunori abe |
Breastopia Namba Hospital
Breast Surgical oncology
2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan
0985-32-7177
k.abe@breastopia.org
Breastopia Namba Hospital
Breastopia Namba Hospital
Self funding
NO
ブレストピアなんば病院(宮崎県)
2013 | Year | 10 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 10 | Month | 03 | Day |
2012 | Year | 12 | Month | 28 | Day |
2013 | Year | 09 | Month | 25 | Day |
2015 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013864
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