UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Title of the study (Brief title)	Eriblin with Trastuzumab for HER2 positive MBC.
Region	Japan

Condition
Condition	HER2 positive metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efiicacy and safety of combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, Overall survival, 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	Combination of Eribulin with Trastuzumab.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histologically confirmed invasive breast cancer in biopsy specimens obtained from the tumor. 2.Presense of overexpression of HER2 in the tumor examined. 3.At least one measurable metastatic lesion other than the breast tumor and axillary lymph nodes detected by CT or MRI before primary registration. 4.ECOG performance status (PS) 0,1,2 5.No surgery, chemotherapy or radiotherapy for any other malignancies within the previous 3 weeks. 6.Adequate organ functions. 7.Availability of written informed consent.
Key exclusion criteria	1. Simultaneous or metachronous (within 5 years) double cancers. 2.Pregnant or breast-feeding women. 3. Psychiatric diseases. 4. Systemic and continuous steroid treatment. 5. with symptomatic brain metastasis 6. Uncontrolled hypertension. 7. Uncontrolled diabetes mellitus or the disease being treated by continuous insulin administration.
Target sample size	30

Research contact person
Name of lead principal investigator	Tadahiko Shien
Organization	Okayama University Hospital
Division name	Breast and Endocrine Surgery
Address	2-5-1 Shikata-cho, Kita-Ku, Okayama, Japan
TEL	086-235-7265
Email	tshien@md.okayama-u.ac.jp

Public contact
Name of contact person	Tadahiko Shien
Organization	Setouchi Breast Project
Division name	Clinical trial committee
Address	2-5-1Shikata-cho, Kita-ku, Okayama
TEL	086-235-7265
Homepage URL
Email	info@setouchi-bp.com

Sponsor
Institute	Setouchi Breast Project
Institute
Department

Funding Source
Organization	Setouchi Breast Project
Organization
Division
Category of Funding Organization	Other
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 11 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 25 Day
Anticipated trial start date	2012 Year 09 Month 25 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 11 Month 09 Day
Last modified on	2016 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010915