UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressing
Title of the study (Brief title)	OMC-BC03
Region	Japan

Condition
Condition	Advanced or metastatic breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	efficacy and safety of Eribulin are evaluating as the first or secondary chemotherapy for advanced or metastatic breast cancer patient without HER2 overexpressing.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Objective Response Rate
Key secondary outcomes	Duration of Response, Progression free survival, Overall survival, Safety, QOL

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	December 1, 2012 to December 31, 2015 Eriburin mesylate 1.4mg/m2, Days 1, 8 q21 days.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. histlogically or cytologically confirmed breast cancer 2. advanced or metastatic breast cancer patient without HER2 overexpressing 3. with interval period of 4 weeks after pot operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation 4. with previous treatment by anthracyclin and taxan for peroperative chemotherapy, and without chemotherapy or only one chemotherapy after advanced or metastasis(However, a history of treatment does not matter about some cases that the use of these drugs are not suitable for due to allergies, comorbidity, and other reasons.). 5. with evaluable lesion by RECIST criteria 6. ECOG performance status 0-2 7. required baseline laboratory parameters (within 1 weeks before registration) WBC > 3,000/mm3, neutophil > 1,500/mm3, Plt > 100,000/mm3, Hb > 9.0 g/dL, AST < 2.0 times ULN adn ALT < 2.0 times ULN, serum creatinine < 1.5 times ULN, normal cardiac function 8. with life expectancy greater than 3 months 9. written informed consent was obtained
Key exclusion criteria	1. serious complication or past history: with symptomatic heart failure, ischemic heart disease within 6 months, liver cirrhosis, psychological disorder treated by antipsychotic drug, uncontrolable diabetes, etc 2. active infection 3. The anamnesis of the hypersensitivity to Eribulin 4. peripheral neuropathy greater than Grade 3 5. male breast cancer 6. under pregnancy or breast-feeding, and possibility (will) of pregnancy. 7. with doctors decision for exclusion
Target sample size	35

Research contact person
Name of lead principal investigator	Mitsuhiko Iwamoto
Organization	Osaka Medical College
Division name	General and Gastroenterological Surgery
Address	2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Email	sur121@poh.osaka-med.ac.jp

Public contact
Name of contact person	Mitsuhiko Iwamoto
Organization	Osaka Medical College
Division name	General and Gastroenterological Surgery
Address	2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	sur121@poh.osaka-med.ac.jp

Sponsor
Institute	General and Gastroenterological Surgery, Osaka Medical College
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 12 Month 17 Day
Last modified on	2017 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011227