Unique ID issued by UMIN | UMIN000003969 |
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Receipt number | R000004786 |
Scientific Title | Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative. |
Date of disclosure of the study information | 2011/04/01 |
Last modified on | 2021/02/05 16:00:05 |
Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
A randomized, controlled study to determine whether S-1 combined with standard postoperative endocrine therapy more effectively inhibits recurrence than standard postoperative endocrine therapy alone in patients with estrogen receptor (ER)-positive, HER2-negative primary breast cancer.
Safety,Efficacy
Confirmatory
Phase III
Invasive Disease-free survival
Overall survival
Distant Disease-free survival
Disease-free survival
Safety
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
Active
2
Treatment
Medicine |
Patients in this group receive standard postoperative endocrine therapy for 5 years.
Patients in this group receive standard postoperative endocrine therapy for 5 years and oral S-1 for 1 year.
20 | years-old | <= |
75 | years-old | >= |
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) ER-positive breast cancer
4) HER2-negative breast cancer
5) Moderate or high risk of recurrence
6) If preoperative chemotherapy, preoperative endocrine therapy, or postoperative chemotherapy was given as previous treatment, the regimen(s) was/were conducted in accordance with the protocol.
7) If postoperative endocrine therapy was being received, the regimen was conducted in accordance with the protocol.
8) If the conserved breast, thoracic wall, or regional lymph nodes underwent radiotherapy, at least 2 weeks have elapsed since the completion of treatment.
9) Within 1 year after surgery and within 6 months after the start of postoperative endocrine therapy
10) An age of 20 years to 75 years
11) A performance status (Eastern Oncology Cooperative Group) of 0 or 1
12) Oral intake is possible.
13) Main organ functions are preserved.
14) Written informed consent was obtained from the patient.
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) Serious complications
6) A history of myocardial infarction within the past 6 months, interstitial pneumonia, or allergy to fluoropyrimidine derivatives
7) Pregnant women, nursing women, or women who want to become pregnant
8) Patients judged to be unsuitable for enrollment in the study by their physicians
1860
1st name | |
Middle name | |
Last name | Masakazu Toi |
Graduate School of Medicine, Kyoto University
Breast Surgery
54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
075-751-3660
toi@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Masahiro Takada |
Graduate School of Medicine, Kyoto University
Breast Surgery
54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
075-751-3660
masahiro@kuhp.kyoto-u.ac.jp
Department of Breast Surgery, Graduate School of Medicine, Kyoto University
Taiho Pharmaceutical Co., Ltd.
Profit organization
NO
2011 | Year | 04 | Month | 01 | Day |
Published
1930
Main results already published
2010 | Year | 07 | Month | 06 | Day |
2010 | Year | 09 | Month | 16 | Day |
2012 | Year | 02 | Month | 01 | Day |
2021 | Year | 01 | Month | 31 | Day |
2010 | Year | 07 | Month | 30 | Day |
2021 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004786
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