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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003969
Receipt No. 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 2017/08/18

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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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 06 Day
Date of IRB
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
2017 Year 08 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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