UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037327 |
|---|---|
| Receipt number | R000042149 |
| Scientific Title | A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2024/01/04 14:48:05 |
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Basic information
Public title
A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Acronym
A pilot study for breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Scientific Title
A pilot study for early evaluation and estimation of prognosis of patients with advanced and/or relapsed breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Scientific Title:Acronym
A pilot study for breast cancer by endocrine and/or CDK4/6 inhibitor combined therapy using estrogen receptor PET
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is the observation of the early change of estrogen receptor in patients with advanced and/or recurrent breast cancer after endocrine therapy with or without palbociclib using 16alpha-18F-fluoro-17beta-estradiol (18F-FES) PET.
Basic objectives2
Others
Basic objectives -Others
It is interesting to observe the early change of estrogen receptor in the patients with advanced and/or recurrent breast cancer by endocrine therapy with or without CDK4/6 inhibitor ( palbociclib or abemaciclib ). This is a pilot study to investigate the change of estrogen receptor 2-4 month after initiation of the therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change rate of FDG-SUVmax
Key secondary outcomes
Tumor mass reduction rate, effective rate, disease-free survival period, survival period, treatment success period
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
| Medicine |
Interventions/Control_1
FES-PET/CT: before and 2-4 months after the beginning of therapy
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. patients with advanced and/or recurrent breast cancer with ER positive and HER2 negative
2. patients more than 20 years-old at the time of the informed consent.
3. patients planned to be treated with endocrine therapy ( Aromatase inhibitors, Tamoxifen, Fulvestrant, Toremifene ) and/or CDK4/6 inhibitors ( Palbociclib or Abemaciclib )
4. patients signed the documentation of the informed consent
Key exclusion criteria
1. patients with the serum fasting glucose level is more than 150mg/dL at the day of entry
2. patients who entered to the other clinical trials 28 days before the day of entry
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ichiei |
| Middle name | |
| Last name | Kuji |
Organization
Saitama Medical University International Medical Center
Division name
Department of Nuclear Medicine
Zip code
350-1298
Address
Yamane 1397-1, Hidaka, Saitama
TEL
042-984-4147
kuji@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ichiei |
| Middle name | |
| Last name | Kuji |
Organization
Saitama Medical University International Medical Center
Division name
Department of Nuclear Medicine
Zip code
350-1298
Address
Yamane 1397-1, Hidaka, Saitama
TEL
042-984-4147
Homepage URL
kuji@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Nuclear Medicine, Saitama Medical University International Medical Center
Name of secondary funder(s)
Department of Nuclear Medicine, Saitama Medical University International Medical Center
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center, Clinical trial IRB
Address
Yamane 1397-1, Hidaka, Saitama
Tel
042-984-4523
chikens@saitama-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
埼玉医科大学国際医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
Results
We compared the values of the positive therapy response (RP) group (lesions with a decrease in the FDG SUVmax >=30% after treatment) and the negative therapy response (RN) group (lesions with a decrease in the FDG SUVmax <30%).
The FES SUVmax was significantly different in both groups before (RPpre and RNpre) and after (RPpost and RNpost) treatment.
The FES value was high before treatment and low after treatment. A decrease trend like FES changes was observed for the FDG SUVmax).
Results date posted
| 2024 | Year | 01 | Month | 04 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042149
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