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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037327 |
Receipt No. | 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 | 2020/07/14 |
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 |
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Condition | |||
Condition | Breast cancer | ||
Classification by specialty |
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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 |
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 |
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Interventions/Control_1 | FES-PET/CT: before and 2-4 months after the beginning of therapy | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Saitama Medical University |
Institute | |
Department |
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 |
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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 | |
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Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042149 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |