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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014096
Receipt No. R000015964
Scientific Title A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer
Date of disclosure of the study information 2014/06/01
Last modified on 2018/03/05

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Basic information
Public title A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer
Acronym A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Scientific Title A phase II study of S-1 (14days-administrarion followed by 7days-rest ) for Metastatic Breast Cancer
Scientific Title:Acronym A phase II study of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of S-1 (14days-administrarion followed by 7days-rest) for Metastatic Breast Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Disease control rate
Progression-free survival
Time to failure
Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1 is administered orally twice daily at a dose of 40-60 mg (80-120 mg/day), depending on the BSA and creatinine-clearance from days 1 to 14, which is followed by 7 days rest.
This treatment is repeated until disease progressive.
Interventions/Control_2
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
80 years-old >
Gender Female
Key inclusion criteria (1)Histologically confermed breast cancer patients of female
(2)Metastatic or recurrent breast cancer.
1) Patients with distant metastasis of breast cancer.
2) Refractory or recurrent breast cancer. Local recurrence is excluded.
(3) Patients submitted written informed consent to participate in this clinical study.
(4)Patients with measurable lesions based on RECIST v.1.1.
(5) no prior chemotherapy or 1 to 2 regimens for metastatic or recurrent breast cancer.
(6) Eastern Cooperative Oncology Group performance status 0,1
(7)
1)previously treated with no orally-administered fluorinated pyrimidine
2)more than 24weeks interval after adjuvant or neoadjuvant chemotherapy of orally-administered fluorinated pyrimidine
(8) The values of laboratory findings within 21 days prior to registration meet all the criteria listed below.
1) neutrophil count: >=1,500/mm3 or leucocytes count: >=3,000/mm3
2)platelet count: >=100,000/mm3
3)total-billirubin:<=2.5 times the upper limit of center standard.
4) AST(GOT)and ALT(GPT): <=2.5 times the upper limit of center standard
5) serum creatinine : within the upper limit of center standard

Key exclusion criteria (1) HER2 positive (IHC:3+ or FISH +)
(2) History of non-breast malignancies within the 5 years prior to study entry
(3) Symptomatic brain metastasis
(4) Diffuse liver meta, or carcinomatous lymphangitis.
(5) In addition, the case that a investigator judged to
be inadequate
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Shimizu
Organization Tokyo Women&#39;s Medical University, Medical Center East
Division name Department of Breast Surgery
Zip code
Address Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan
TEL 03-3810-1111
Email shimitsu@dnh.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Hirano
Organization Tokyo Women&#39;s Medical University, Medical Center East
Division name Department of Breast Surgery
Zip code
Address Nishiogu 2-1-10, Arakawa-ku, Tokyo, Japan
TEL 03-3810-1111
Homepage URL
Email ahirasu@dnh.twmu.ac.jp

Sponsor
Institute Tokyo Women&#39;s Medical University
Institute
Department

Funding Source
Organization Tokyo Women&#39;s Medical University
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 東京女子医科大学東医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 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
2014 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 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
2014 Year 05 Month 28 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015964

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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