UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029954 |
|---|---|
| Receipt number | R000034207 |
| Scientific Title | Exploratory observational study on prediction based on PK / PD / PGx of efficacy and safety of palbociclib for patients with inoperable or recurrent breast cancer |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2022/05/20 15:16:18 |
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Basic information
Public title
Exploratory observational study on prediction based on PK / PD / PGx of efficacy and safety of palbociclib for patients with inoperable or recurrent breast cancer
Acronym
NCCH1701
Scientific Title
Exploratory observational study on prediction based on PK / PD / PGx of efficacy and safety of palbociclib for patients with inoperable or recurrent breast cancer
Scientific Title:Acronym
NCCH1701
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate predictive factors of therapeutic effects and adverse events by pharmacokinetics (PK) / pharmacodynamics (PD) / pharmacogenomics (PGx) in patients receiving parbociclib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
Overall survival
Incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Male and Female
Key inclusion criteria
1. Patients aged 20 years or older who are diagnosed as inoperable or recurrent breast cancer and scheduled to receive palbociclib.
2. Patients who have provided a written informed consent to participate in the study.
Key exclusion criteria
No setting
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kan |
| Middle name | |
| Last name | Yonemori |
Organization
National Cancer Center
Division name
Breast and Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
kyonemor@ncc.go.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Noguchi |
Organization
National Cancer Center Hospital
Division name
Department of Breast and Medical Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL
03-3542-2511
Homepage URL
enoguchi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer 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
National cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 11 | Month | 14 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The efficacy is assessed based on the imaging evaluation conducted by each doctors.
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034207
| 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 |
