UMIN-CTR Clinical Trial

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'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'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's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women'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

Contact us.