UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Title of the study (Brief title)	Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes

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, Trastuzumab and Pertuzumab
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	80 years-old >=
Gender	Female
Key inclusion criteria	1) Patients with pathologically confirmed metastatic/reccurent breast cancer. 2) HER2 positive. 3) Age >=20 and 80=< 4) Performance status (PS, ECOG scale): 0-2. 5) History of one or more cytotoxic agent and anti-HER2 therapy. 6) Adequate organ functions, measured as follows: Neutrophils: >= 1,500/mm3 Platelet: >= 100,000/mm3 Total birilbin: <= 1.5 x ULN AST (GOT): <= 3.0 x ULN ALT (GPT): <= 3.0 x ULN Serum creatinine: <= 1.5 x ULN 7) LVEF: >= 50% 8) Written informed consent.
Key exclusion criteria	1) Past history of severe hypersensitivity. 2) History of eribulin use during 6 months prior to consent. 3) Active multiple primary malignancy. 4) Patients with uncontrolled infection. 5) Patient with disease requiring emergent intervention. 6) Patients with progressive brain metastasis requiring treatment during 6 months prior to consent. 7) Patients with severe complications. 8) Pregnant or breastfeeding. 9) Patients who deny contraception during this study. 10) Any other cases that the attending doctor judges not appropriate to enroll to this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Mikiya Ishihara
Organization	Mie University Hospital
Division name	Cancer Center
Address	2-174 Edobashi, Tsu, Mie, Japan
TEL	059-231-5296
Email	mishihara@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Mikiya Ishihara
Organization	Mie University Hospital
Division name	Dep. of Hematology and Oncology
Address	2-174 Edobashi, Tsu, Mie, Japan
TEL	059-232-1111
Homepage URL
Email	mishihara@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	Mie University Hospital Dep. of Hematology and Oncology
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	2013 Year 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 10 Day
Anticipated trial start date	2013 Year 10 Month 10 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 10 Day
Last modified on	2018 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014023