UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015838 |
|---|---|
| Receipt number | R000018430 |
| Scientific Title | Phase 2 clinical study of evaluation of efficacy of switch to eribulin chemotherapy in patients with locally advanced breast cancer or metastatic breast cancer who are not responsive to combination regimen of Docetaxel, Doxorubicin and Cyclophosphamide (TAC) and continuation of TAC chemotherapy in responding patients to TAC |
| Date of disclosure of the study information | 2014/12/03 |
| Last modified on | 2014/12/03 21:55:23 |
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Basic information
Public title
Phase 2 clinical study of evaluation of efficacy of switch to eribulin chemotherapy in patients with locally advanced breast cancer or metastatic breast cancer who are not responsive to combination regimen of Docetaxel, Doxorubicin and Cyclophosphamide (TAC) and continuation of TAC chemotherapy in responding patients to TAC
Acronym
To evaluation of efficacy of switch to eribulin chemotherapy in breast cancer patients who are not responsive to TAC and continuation of TAC in responding patients to TAC
Scientific Title
Phase 2 clinical study of evaluation of efficacy of switch to eribulin chemotherapy in patients with locally advanced breast cancer or metastatic breast cancer who are not responsive to combination regimen of Docetaxel, Doxorubicin and Cyclophosphamide (TAC) and continuation of TAC chemotherapy in responding patients to TAC
Scientific Title:Acronym
To evaluation of efficacy of switch to eribulin chemotherapy in breast cancer patients who are not responsive to TAC and continuation of TAC in responding patients to TAC
Region
| Japan |
Condition
Condition
Locally advanced and/or metastatic breast cancer patients
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy for TAC non-responding patients who recieved eribulin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate radiological response to eribulin in TAC non-responding patients
Key secondary outcomes
Base
Study type
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
18Ffluorodeoxyglucose positron emission tomography combined with computed tomography and diffuse optical spectroscopy
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
Male and Female
Key inclusion criteria
Patinet who got informed consent on paper
patients with 20 year old or more
Invasive breast cancer was confirmed by pathology
Patients with locally advanced or metastatic breast cancer
Tumor can be measured by RECIST criteria
Key exclusion criteria
Patients who do not have informed consent on paper
Patients who have uncontroled severe diabetes, infection , or other malignancy
Patients whom doctor consider this treatment are suitable for.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
Saitama medical university International medical center
Division name
Department of breast oncology
Zip code
Address
1397-1Yamane, Hidaka, Saitama
TEL
81-42-984-4670
tsaeki@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Ueda |
Organization
Saitama Medical Univeristy International Medical Center
Division name
Dept of breast oncology
Zip code
Address
1397-1Yamane, Hidaka, Saitama
TEL
81-42-984-4670
Homepage URL
syueda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Univeristy International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Dept of breast oncology Saitama Medical Univeristy International Medical Center
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
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
| 2014 | Year | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 03 | 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 | 12 | Month | 03 | Day |
Last modified on
| 2014 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018430
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
