UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009296
Receipt No. R000010915
Scientific Title Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Date of disclosure of the study information 2012/11/09
Last modified on 2016/12/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Acronym Eriblin with Trastuzumab for HER2 positive MBC.
Scientific Title Combination therapy of Eribulin with Trastuzumab for HER2 positive metastatic breast cancer.
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Tadahiko Shien
Organization Okayama University Hospital
Division name Breast and Endocrine Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-Ku, Okayama, Japan
TEL 086-235-7265
Email tshien@md.okayama-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tadahiko Shien
Organization Setouchi Breast Project
Division name Clinical trial committee
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2012 Year 09 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.