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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029294
Receipt No. R000033491
Scientific Title Fulvestrant with additional palbociclib in advanced or metastatic HR-positive HER2-negative breast cancer after progression to fulvestrant monotherapy. -FUTURE trial a multicenter study-
Date of disclosure of the study information 2017/12/01
Last modified on 2018/09/28

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Basic information
Public title Fulvestrant with additional palbociclib in advanced or metastatic HR-positive HER2-negative breast cancer after progression to fulvestrant monotherapy.
-FUTURE trial a multicenter study-
Acronym JBCRG-M07 (FUTURE)
Scientific Title Fulvestrant with additional palbociclib in advanced or metastatic HR-positive HER2-negative breast cancer after progression to fulvestrant monotherapy.
-FUTURE trial a multicenter study-
Scientific Title:Acronym JBCRG-M07 (FUTURE)
Region
Japan

Condition
Condition advanced or metastatic HR-positive HER2-negative breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1)Collect Information of PFS and safety in Fulvestrant + Palbociclib for patients with resistant Fulvestrant
2)Collect Information of PFS in Fulvestrant as 1st and 2nd line therapy for HR-positive MBC
3)We assessed the biomarker and mechanism of drug resistance on Fulvestrant monotherapy and Fulvestrant + Palbociclib
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival: PFS
Key secondary outcomes Overall Survival
Overall response rate
Time to treatment failure (TTF)
Safety
Translational Research

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Additional palbpciclib after progression to fulvestrant
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
80 years-old >=
Gender Female
Key inclusion criteria 1st resistration
1.Historically confirm breast cancer
2.Age: 20-80years postmenopausal woman
3.HER2 negative
4.ER and/or PgR positive, HER2 negative
5.Metastatic or locally advanced breast cancer
6.Patients received Fulvestrant as 1st or 2nd line therapy
7.PS 0 - 2
8.Acceptable for chemotherapy for neoadjuvant and adjuvant setting
9.Permit 1 line chemotherapy for metastatic breast cancer.
10.Permit 1 line hormone therapy for metastatic breast cancer before fulvestrant. (There are no including one line that stop or change hormone therapy before resistant, such as switch TAM to AI, AI to TAM as adjuvant Tx, one year or more from stop adjuvant treatment, discontinue hormone therapy base on adverse event.)
11.Excepted that more than 3 month overall survival
12.No concern about measurable disease baced on RECIST
13.Meet the condition necessary for patients within 4 weeks before resistration
(1)Neutrophil count: >=1,500/mm3
(2)Platelet count: >=100,000/mm3
(3)Hemoglobin: >=9.0 g/dL
(4)Total bilirubin: <=1.5 mg/dL
(5)AST(GOT), ALT(GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis)
(6)Serum creatinine: <=1.5 mg/dL
14.Informed consent is obtainable

2nd resistration
1.Patients have confirmed failure to Fulvestrant as 1st or 2nd line therapy
2.ECOG PS: 0-2
3.Excepted that more than 3 month overall survival
4.No concern about measurable disease baced on RECIST
5.Meet the condition necessary for patients within 4 weeks before resistration
(1)Neutrophil count: >=1,500/mm3
(2)Platelet count: >=100,000/mm 3
(3)Hemoglobin: >=9.0 g/dL
(4)Total bilirubin: <=1.5 mg/dL
(5)AST(GOT), ALT(GPT): <=2.5 times the ULN (<=5 times in those with liver metastasis)
(6)Serum creatinine: <=1.5 mg/dL
6.Having provided voluntary written consent for participation in this study.
Key exclusion criteria 1st resistration
1.Patients received CDK4/6 inhibitor as metastatic therapy
2.Patients have confirmed failure to Fulvestrant
3.Patients received antibiotics, antifungal drug, antiviral drug and treatment for active infection of HBV and HCV.
4.Pregnancy or lactation
5.Brain metastasis and CNS metastatis
6.With another reasons recognized as inadequate to participate in this study by doctors

2nd resistration
1.Brain metastasis and CNS metastatis
2.With another reasons recognized as inadequate to participate in this study by doctors

Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)Naoki Niikura 2)Shigehira Saji
Organization 1)Tokai University School of Medicine
2)Fukushima Medical University
Division name 1) Department of Breast and Endocrine Surgery 2) Department of Medical Oncology
Zip code
Address 1) 143 Shimokasuya, Isehara-shi, Kanagawa 259-1193 JAPAN 2) 1 Hikariga-oka, Fukushima City, 960-1295 JAPAN
TEL 0463-93-1121
Email niikura@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Adminstrative office
Zip code
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL http://www.jbcrg.jp/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group
Institute
Department

Funding Source
Organization AstraZeneca K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 東海大学医学部(神奈川県)、福島県立医科大学(福島県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 01 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
2017 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2017 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

Management information
Registered date
2017 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033491

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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