UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014107 |
|---|---|
| Receipt number | R000016421 |
| 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 |
| Date of disclosure of the study information | 2014/05/29 |
| Last modified on | 2019/10/02 16:13:42 |
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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
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
abe@belle.shiga-med.ac.jp
Sponsor or person
Institute
SONG (South Osaka Network Group for Breast Cancer)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016421
