UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035863
Receipt number 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 2024/02/01 11:45:36

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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 or person

Institute

CSPOR-BC

Institute

Department

Personal name



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

Completed

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

2024 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

2024 Year 02 Month 01 Day



Link to view the page

Value
https://center6.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