UMIN-CTR Clinical Trial

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
Last 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
1st 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