UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029294 |
|---|---|
| Receipt number | 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 | 2023/10/02 12:07:39 |
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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 | 1)Kenichi 2) Hiroshi |
| Middle name | |
| Last name | 1)Watanabe 2)Ishiguro |
Organization
1)National Hospital Organization Hokkaido Cancer Center
2)Saitama Medical University International Medical Center
Division name
1) Breast Surgery, 2) Breast Oncology Service
Zip code
003-0804
Address
1) 2-3-54 Kikusui-4-jyo, Shiroishi-ku, Sapporo-shi, Hokkaido
TEL
0463-93-1121
niikura@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head office
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group
Institute
Department
Personal name
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
N/A
Address
N/A
Tel
N/A
N/A
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
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
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033491
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