UMIN-CTR Clinical Trial

Basic information
Public title	Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Acronym	Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Scientific Title	Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Scientific Title:Acronym	Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative.
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Invasive Disease-free survival
Key secondary outcomes	Overall survival Distant Disease-free survival Disease-free survival Safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in this group receive standard postoperative endocrine therapy for 5 years.
Interventions/Control_2	Patients in this group receive standard postoperative endocrine therapy for 5 years and oral S-1 for 1 year.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Female
Key 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.
Key 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
Target sample size	1860

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masakazu Toi
Organization	Graduate School of Medicine, Kyoto University
Division name	Breast Surgery
Zip code
Address	54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Email	toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masahiro Takada
Organization	Graduate School of Medicine, Kyoto University
Division name	Breast Surgery
Zip code
Address	54 Kawaracho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Homepage URL
Email	masahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Breast Surgery, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1930
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 07 Month 06 Day
Date of IRB	2010 Year 09 Month 16 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 07 Month 30 Day
Last modified on	2021 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004786