UMIN-CTR Clinical Trial

Basic information
Public title	A phase 2 study of eribulin in combination with pertuzumab and trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer
Acronym	SONG-02
Scientific Title	A phase 2 study of eribulin in combination with pertuzumab and trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer
Scientific Title:Acronym	SONG-02
Region	Japan

Condition
Condition	Advanced or recurrent HER2-positive breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of eribulin in combination with pertuzumab and trastuzumab as second line or later therapy for patients with advanced or recurrent HER2-positive breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival (PFS)
Key secondary outcomes	Response rate (RR), 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	Administration of eribulin, pertuzumab and trastuzumab every three weeks until disease progression or occurring adverse events difficult to continue.
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. Histologically confirmed invasive breast cancer 2. Second line or later therapy of Stage IIIB,IIIC,IV or advanced / recurrent breast cancer previously treated with anti-HER2 therapy 3. HER2 positive as determined by score of 3+ on IHC staining or gene amplification by FISH 4. Previous treatment with anthracyclines or taxanes 5. ECOG performance status(PS) 0-2 6. Adequate organ function shown in laboratory measurements within 14 days prior to enrollment Neutrophil count >=1500/mm3 Platelet count >=75,000/mm3 Hemoglobin >=8.0g/dL Total serum bilirubin <=2.0mg/dL AST and ALT <100IU/L Serum creatinine <=1.5mg/dL 7. Echocardiographic ejection fraction >=50% 8. Written informed consent for study entry
Key exclusion criteria	1. History of drug allergies with eribulin or pertuzumab or trastuzumab 2. Pregnant females or females of child-bearing potential2 3. Serious cardiac disorder 4. Not suitable for participation with any other reasons
Target sample size	43

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Abe
Organization	Bell Land General Hospital
Division name	Breast Center
Zip code
Address	500-3 Higashiyama, Naka-ku, Sakai, Osaka, Japan
TEL	072-234-2001
Email	abe@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hajime Abe
Organization	Bell Land General Hospital
Division name	Breast Center
Zip code
Address	500-3 Higashiyama, Naka-ku, Sakai, Osaka, Japan
TEL	072-234-2001
Homepage URL
Email	abe@belle.shiga-med.ac.jp

Sponsor
Institute	SONG (South Osaka Network Group for Breast Cancer)
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)

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	2014 Year 05 Month 29 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	Terminated
Date of protocol fixation	2014 Year 04 Month 07 Day
Date of IRB	2014 Year 04 Month 30 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 05 Month 29 Day
Last modified on	2019 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016421