UMIN-CTR Clinical Trial

Basic information
Public title	Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Acronym	Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Scientific Title	Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Scientific Title:Acronym	Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	1)Time to treatment failure 2)Overall survival 3)Objective response rate 4)Clinical benefit rate 5)Parcentage of participants with over Grade 3 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	Female
Key inclusion criteria	Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer patients who have completed postoperative hormone therapy for more than 1 year or who have not been treated with hormone therapy and who meet all of the following criteria are included. 1) Histologically confirmed advanced/metastatic breast cancer 2) Premenopausal or postmenopausal patients aged 20 years or older 3) Confirmed diagnosis of ER positive breast cancer 4) Confirmed diagnosis of HER2 negative breast cancer 5) Adequate organ and bone marrow function 6) Easter Cooperative Oncology Group [ECOG]0-1 7) No prior systemic chemotherapy or 1st line prior systemic chemotherapy 8) Signed written informed consent
Key exclusion criteria	1) Recurrence during postoperative hormone therapy or within 1 year from completion of treatment 2) Known uncontrolled or symptomatic central nervous system metastases 3) Patients with advanced symptomatic visceral spread that are at risk of life threatening complication in the short term 4) Prior endocrine therapy for advanced/metastatic breast cancer 5) Known interstitial lung disease on imaging 6) Known uncontrolled infection 7) Current pregnancy and lactation or possibility of pregnancy 8) Known drug allergy to any of study drugs 9) Assessment by investigator that subject unable to comply with protocol
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Breast Surgery
Zip code	510-8567
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Email	mizunoy729@yokkaichihp01.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Mizuno
Organization	Yokkaichi Municipal Hospital
Division name	Breast Surgery
Zip code	510-8567
Address	2-2-37 Shibata Yokkaichi-city Mie
TEL	059-354-1111
Homepage URL
Email	mizunoy729@yokkaichihp01.jp

Sponsor
Institute	Breast Surgery, Yokkaichi Municipal Hospital
Institute
Department

Funding Source
Organization	Breast Surgery, Yokkaichi Municipal Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional Review Board, Yokkaichi Municipal Hospital
Address	2-2-37 Shibata Yokkaichi-city Mie
Tel	059-354-1111
Email	chiken@yokkaichihp01.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	2021 Year 04 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	Open public recruiting
Date of protocol fixation	2021 Year 03 Month 01 Day
Date of IRB	2021 Year 03 Month 22 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2026 Year 12 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	2021 Year 04 Month 14 Day
Last modified on	2021 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050098