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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035863
Receipt No. R000040855
Scientific Title Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer
Date of disclosure of the study information 2019/02/20
Last modified on 2019/07/17

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Basic information
Public title Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer
Acronym Palbociclib Cohort Study
Scientific Title Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer
Scientific Title:Acronym Palbociclib Cohort Study
Region
Japan

Condition
Condition postmenopausal patients with unresectable and metastatic hormone receptor-positive breast cancer,
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims 1) to determine the efficacy and safety of palbociclib treatment as a daily clinical therapy in postmenopausal patients with unresectable and metastatic hormone receptor-positive breast cancer, and 2) to evaluate the effects of palbociclib treatment on the subsequent treatment that the research subjects will receive in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival (PFS) in each treatment line.
Key secondary outcomes 1) overall survival,
2) clinical benefit rate (CBR)
3) AEs
4) patient-reported outcomes of the common terminology criteria for adverse events (PRO-CTCAE)
5) PFS
6) CBR with the next treatment
7) AEs caused by the subsequent treatment,
8) PRO-CTCAE with the subsequent treatment
9) reasons for selecting the treatment.

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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Postmenopausal patients with ER-positive
Key exclusion criteria Patients who is not adopt endocrine therapy.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Ishikawa
Organization Tokyo Medical University Hospital
Division name breast surgery
Zip code 160-0023
Address 6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
TEL 03-3342-6111
Email tsihik55@gmail.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Ishikawa
Organization Tokyo Medical University Hospital
Division name Breast surgery
Zip code 160-0023
Address 6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
TEL 03-3342-6111
Homepage URL
Email tsihik55@gmail.com

Sponsor
Institute CSPOR-BC
Institute
Department

Funding Source
Organization CSPOR-BC
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical University Hospital
Address 6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
Tel 03-3342-6111
Email tsihik55@gmail.com

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
2019 Year 02 Month 20 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 03 Day
Date of IRB
2019 Year 01 Month 17 Day
Anticipated trial start date
2019 Year 02 Month 18 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2019 Year 02 Month 13 Day
Last modified on
2019 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040855

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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