UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013928 |
|---|---|
| Receipt number | 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 10:43:36 |
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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
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
bc03.dc@jaccro.or.jp
Sponsor or person
Institute
Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016241
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