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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035533
Receipt No. R000040483
Scientific Title Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Date of disclosure of the study information 2019/01/13
Last modified on 2019/01/13

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Basic information
Public title Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Acronym SBP-11
Scientific Title Fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer -observational study
Scientific Title:Acronym SBP-11
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 the safety of fulvestrant and CDK4/6 inhibitor as first line hormonal therapy for locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS
Key secondary outcomes CBR, OS, ORR, TTF, Safety, compliance

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 Locally advanced/ metastatic disease for Patients with Hormone receptor positive HER2 negative breast cancer pretreated with no hormonal therapy for MBC.

1 Adaptation for Fulvestrant and CDK4/6 inhibitor and the informed consent is obtained.
2 age >=20,female, regardless of menstrual status.
3 locally advanced/ metastatic breast cancer histologically confirmed
4 Hormone receptor positive breast cance confirmed by Immunohistochemically.
5 HER2 negative breast cance confirmed by Immunohistochemically or ISH.
6 ECOG PS: 0-2
7 non-hematological AE( CTCAE v4.0-JCOG) <= grade 2
7 no major organ dysfunction nor bone marrow dysfunction.
8 with or without evaluable lesions (with evaluable lesions preferred)
9 1st line hormonal therapy for MBC ( 1regimen fo chemotherapy is allowed)
10 with documented informed consent.
Key exclusion criteria 1 with life-threatenings
2 symptomatic brain metastasis
3 eligible for inclusion criteria of PALOMA-3
4 pretreated with hormonal therapy for MBC
5 pregnancy or breast feeding or unwilling to contraception
6 long QT syndrome or similar diseases
7 Electrolyte abnormality causing long QT syndrome
8 uncontrolled hypertension, symptomatic heart failure, unstable angina, severe arrhythmia or acute myocardial infarction within 12 months
9 obvious pulmonary fibrosis or interstitial pneumonia
10 active infection
11 other severe comorbidity
12 another active cancer
13 allergic for fulvestrant or CDK4/6 inhibitor
14 other inappropriate patients
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Kubo
Organization Fukuyama City Hospital
Division name Department of Breast and thyroid surgery
Zip code
Address 5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL 084-941-5151
Email kubokubobo01-safetyaddress01@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taira Naruto
Organization Setouchi Breast Project Comprehensive Support Organization
Division name Clinical trial committee
Zip code
Address 2-5-1, Shikata, Kita-ku, Okayama
TEL 086-235-7265
Homepage URL
Email info@setouchi-bp.com

Sponsor
Institute Setouchi Breast Project Comprehensive Support Organization
Institute
Department

Funding Source
Organization Setouchi Breast Project Comprehensive Support Organization
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
Address
Tel
Email

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 01 Month 13 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 Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information clinical data

Management information
Registered date
2019 Year 01 Month 13 Day
Last modified on
2019 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040483

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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