UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012018 |
|---|---|
| Receipt number | R000014023 |
| Scientific Title | Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer. |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2018/03/19 14:53:24 |
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Basic information
Public title
Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Acronym
Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Scientific Title
Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mikiya Ishihara |
Organization
Mie University Hospital
Division name
Cancer Center
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-231-5296
mishihara@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikiya Ishihara |
Organization
Mie University Hospital
Division name
Dep. of Hematology and Oncology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
mishihara@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
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)
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
| 2013 | Year | 10 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014023
