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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013928
Receipt No. R000016241
Scientific Title Phase II study of Eribulin every other week maintenance therapy, after induction therapy of Eribulin on day1 and 8 for 3 cycles, in patients with hormone receptor positive and HER2-negative advanced recurrent breast cancer.
Date of disclosure of the study information 2014/05/13
Last modified on 2019/03/22

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Basic information
Public title Phase II study of Eribulin every other week maintenance therapy, after induction therapy of Eribulin on day1 and 8 for 3 cycles, in patients with hormone receptor positive and HER2-negative advanced recurrent breast cancer.
Acronym JACCRO BC-03 study
Scientific Title Phase II study of Eribulin every other week maintenance therapy, after induction therapy of Eribulin on day1 and 8 for 3 cycles, in patients with hormone receptor positive and HER2-negative advanced recurrent breast cancer.
Scientific Title:Acronym JACCRO BC-03 study
Region
Japan

Condition
Condition Hormone receptor positive and HER2-negative advanced recurrent breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Eribulin every other week treatment after induction 3-cycle treatment (Eribulin on day1 and 8 for 2 weeks in 3 weeks cycle) in patients with hormone receptor positive and HER2-negative advanced recurrent breast cancer.
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 (Patients who was able to shift to maintenance therapy)
Key secondary outcomes Overall Survival
Time to Treatment Failure
Response Rate
Safety

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 Eribulin
(1) Induction therapy:Administer Eribulin 1.4mg/m2 intravenously in 2 to 5 minutes on day1 and 8 every 3 weeks for 3 cycles.(2) Maintenance therapy:Administer Eribulin 1.4mg/m2 intravenously in 2 to 5 minutes on day1 every 2 weeks in patients achieved CR, PR or SD at the end of induction therapy.
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 (1) Female patients with histologically diagnosed as invasive breast cancer. (2) Hormone receptor positive and HER-2 negative patients. (3) Age; more than 20 years old. (4) ECOG Performance status 0-2. (5) Metastatic or inoperable locally advanced breast cancer. (6) Had prior chemotherapy with anthracycline or taxane. (7) Patients without symptomatic brain metastasis. (8) Patients meeting at least one of following criteria; 1) Available measurable lesion according to RECIST Version 1.1. 2) Available unmeasurable osteolytic bone lesion. 3) Available unmeasurable mixed bone lesion. (9) Patients with enough organ function for study treatment within 14 days before enrollment; 1) Neu>=1,500/mm3. 2) PLT>=7.5x10 4/mm3. 3) Hb>=9.0g/dL. 4) AST<=100 IU/L (<=200 IU/L in patients with liver metastasis). 5) ALT<=100 IU/L (<=200 IU/L in patients with liver metastasis). 6) Total Bilirubin <= 1.5mg/dL. 7) Creatinine <= 1.5mg/dL. 8) Peripheral sensory neuropathy; Grade <= 2. 10) Non-hematological toxicity (excluding alopecia, fatigue and malaise); Grade <=1. (10) Life expectancy of more than 3 months. (11) Written informed consent.
Key exclusion criteria (1) Active multiple malignancy (Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval). (2) Patients with severe infection. (3) Patients with following severe concomitant disease; 1) Uncontrolled cardiovascular disease including ischemic cardiac disease and arrhythmia. 2) Myocardial infarction within the previous 6 months. 3) Hepatic cirrhosis. 4) Active hepatitis. 5) Interstitial lung disease or pulmonary fibrosis. 6) Hemorrhagic tendency. (4) Patients treated with steroid for brain metastasis or available carcinomatous meningitis. (5) Patients with prior history of severe hypersensitivity. (6) Prior eribulin treatment for breast cancer. (7) Patients with clinically significant psychiatric disease assessed as difficult for this study inclusion. (8) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (9) Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Ito
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research, Ariake
Division name Breast medical oncology
Zip code 135-8550
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Email yito@jfcr.or.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Fujii
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code 104-0061
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email bc03.dc@jaccro.or.jp

Sponsor
Institute Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel 03-5579-9882
Email jaccro@jaccro.or.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 がん研有明病院(東京都)ほか、JACCRO参加施設

Other administrative information
Date of disclosure of the study information
2014 Year 05 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 60
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
2014 Year 04 Month 23 Day
Date of IRB
2014 Year 04 Month 23 Day
Anticipated trial start date
2014 Year 05 Month 13 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016241

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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