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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011860
Receipt No. 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

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Basic information
Public title Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Acronym Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Scientific Title Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Scientific Title:Acronym Clinical study of Adjuvant chemotherapy with TS-1 for breast cancer
Region
Japan

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

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

Assessment
Primary outcomes Primary endpoint :
disease-free survival
Key secondary outcomes Secondary endpoint :overall survival, relapse-free survival, relative dose intensity, and safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT
Interventions/Control_2 TS-1
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

Not applicable
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) 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
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) 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
Target sample size 380

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidemi Furusawa
Organization Breastopia Namba Hospital
Division name Breast Surgical oncology
Zip code
Address 2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan
TEL 0985-32-7177
Email k.abe@breastopia.org

Public contact
Name of contact person
1st name
Middle name
Last name Katsunori abe
Organization Breastopia Namba Hospital
Division name Breast Surgical oncology
Zip code
Address 2-112-1 , Maruyama , Miyazaki-city , Miyazaki , 880-0052 , Japan
TEL 0985-32-7177
Homepage URL
Email k.abe@breastopia.org

Sponsor
Institute Breastopia Namba Hospital
Institute
Department

Funding Source
Organization Breastopia Namba Hospital
Organization
Division
Category of Funding Organization Self funding
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 ブレストピアなんば病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 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 Terminated
Date of protocol fixation
2012 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 25 Day
Last modified on
2015 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=R000013864

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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