UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030410 |
|---|---|
| Receipt number | R000034726 |
| Scientific Title | Evaluation of treatment efficacy of metastatic breast cancer |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2022/06/19 11:03:28 |
* 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
Evaluation of treatment efficacy of metastatic breast cancer
Acronym
PET Recurrence
Scientific Title
Evaluation of treatment efficacy of metastatic breast cancer
Scientific Title:Acronym
PET Recurrence
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of treatment efficacy of FDG-PET in metastatic breast cancers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival according to metabolic response of FDG-PET.
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
FDG-PET examination after start of treatment between 2 to 6 weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Metastatic breast cancer patients
Key exclusion criteria
None
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyoshi |
Organization
Hyogo College of Medicine
Division name
Division of Breast and Endocrine, Department of Surgery
Zip code
663-8501
Address
Mucogawa 1-1, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798456374
ymiyoshi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Miyoshi |
Organization
Hyogo College of medicine
Division name
Division of Breast and Endocrine, Department of Surgery
Zip code
663-8501
Address
Mucogawa 1-1, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798456374
Homepage URL
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicne
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
Institutional Review Board of Hyogo College of Medicine
Address
Nukogawa 1-1, Nishinomiya City
Tel
0798456374
rinri@hyo-med.ac.jp
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
| 2017 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
44
Results
FDG-PET/CT base-line and after one cycle of systemic therapy in 44 recurrent and metastatic breast cancer patients were evaluated. Reduction of SUVmax values were calculated and divided into metabolic responder and non-responder. The mean reduction rate of SUVmax in responders were significantly lower than that in the non-responder (p<0.0001). Responders showed significantly longer PFS than non-responders (p=0.0038).
Results date posted
| 2022 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Metastatic breast cancer patients who receive chemotherapy.
Participant flow
Consecutively recruited of patients who receive chemotherapy in the Hyogo Medical School Hospital.
Adverse events
No adverse events.
Outcome measures
Progression-free survival and SUVmax of FDG-PET examination.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034726
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
