Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.

Conditions

Breast cancer

Toi M, Imoto S, Ishida T, Ito Y, Iwata H, Masuda N, Mukai H, Saji S, Shimizu A, Ikeda T, Haga H, Saeki T, Aogi K, Sugie T, Ueno T, Kinoshita T, Kai Y, Kitada M, Sato Y, Jimbo K, Sato N, Ishiguro H, Takada M, Ohashi Y, Ohno S.

2021-01-0143 citations

10.1016/s1470-2045(20)30534-9

Abstract GS1-09: Addition of S-1 to endocrine therapy in the post-operative adjuvant treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative primary breast cancer: A multicenter, open-label, phase 3 randomized trial (POTENT trial)

Masakazu Toi, Shigeru Imoto, Takanori Ishida, Yoshinori Ito, Hiroji Iwata et al. (25 authors)

Cancer Research2020-02-151 citations

10.1158/1538-7445.sabcs19-gs1-09

Safety and feasibility of adjuvant chemotherapy with S-1 in Japanese breast cancer patients after primary systemic chemotherapy: a feasibility study.

Shigekawa T, Osaki A, Sekine H, Sato N, Kanbayashi C, Sano H, Takeuchi H, Ueda S, Nakamiya N, Sugitani I, Sugiyama M, Shimada H, Hirokawa E, Takahashi T, Saeki T.

2015-04-104 citations

10.1186/s12885-015-1289-7

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Invasive Disease-free survival	—

Secondary

Measure	Time frame
Overall survival Distant Disease-free survival Disease-free survival Safety	—

Countries

Japan

Contacts

Public ContactMasahiro Takada

Graduate School of Medicine, Kyoto University Breast Surgery

masahiro@kuhp.kyoto-u.ac.jp075-751-3660

Outcome results

None listed