UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008879
Receipt No. R000010415
Scientific Title A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer
Date of disclosure of the study information 2012/09/07
Last modified on 2012/09/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer
Acronym A study of TS-1 alternate-day dosing for Breast cancer
Scientific Title A PhaseII Study of Dose Schedule of TS-1 for Metastatic/Advanced Breast Cancer
Scientific Title:Acronym A study of TS-1 alternate-day dosing for Breast cancer
Region
Japan

Condition
Condition Metastatic/Advanced Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of TS-1 Alternate-day dosing with Metastatic/Advanced Breast Cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival (PFS)
Key secondary outcomes

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 Dose the TS-1 of 80mg/m2 in alternate-day.
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

Not applicable
Gender Female
Key inclusion criteria 1)Histologically confirmed primary breast cancer
2)Satisfies any of the following in a diagnosis of metastatic breast cancer.
1.Inoperable for distant metastasis in an initial diagnosis.
2.The cause that recurred or progressed is distant metastasis.
3)Evaluable lesions are at least one or more.
4)Received no previous chemotherapy, or only two regimen.
5)Age >= 20 years
6)ECOG performance status of 0 or 1
7)Hormonal therapies-resistant and Satisfies any of the following.
1.ER-negative breast cancer
2.Hormonal therapies-resistant in the therapy for metastatic breast cancer.
3.A recurrence during six months after adjuvant hormonal therapies or the surgery.
8)Satisfies all of the following about precedent treatment (including the adjuvant setting).
1.Pass more than 7 days, after the hormonal therapies end.
2.Pass more than 14 days, after the radiotherapy end.
9)Results from a laboratory test meet the following
WBC >= 3,500/mm3
Neu >= 2,000/mm3
Hb >= 9.0g/dL
Plt >= 100,000/mm3
T-Bil <= 1.5mg/dL
AST <= 100 IU/L
ALT <= 100 IU/L
Cre <= 1.2mg/dL
Ccr >= 60mL/min
10)Be able to be administered orally.
11)Written informed consent.
Key exclusion criteria 1)Active double cancer.
2)Watery diarrhea.
3)Require administration of flucytosine, phenytoin, and warfarin.
4)The metastases to brain which require measures for the brain hypertension and urgent brain irradiation.
5)Extensive liver metastases, or lymphatic vessel-related metastases to lung with dyspnea.
6)A lesion targeted for an evaluation is only one, and there is an enforcement history of the radiotherapy to the part.
7)Pleural effusion, ascitic fluid, pericardial effusion to need urgent treatment.
8)Severe infections being suspected.
9)Interstitial pneumonia or pulmonary fibrosis.
10)HBs antigen is positive.
11)The diabetes patients with difficult control or during treatment with insulin.
12)Serious mental disorder.
13)Pregnant woman, a nursing mother or has a hope for the pregnancy.
14)The patients who are inappropriate to the study which judged by doctors.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Oura
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1, Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Homepage URL
Email

Sponsor
Institute Wakayama Medical University, Department of Thoracic and Cardiovascular Surgery
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 07 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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 07 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
2012 Year 09 Month 07 Day
Last modified on
2012 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010415

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.