UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010844 |
|---|---|
| Receipt number | R000012460 |
| Scientific Title | Phase II trial with eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer |
| Date of disclosure of the study information | 2013/06/15 |
| Last modified on | 2013/05/30 17:19:51 |
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Basic information
Public title
Phase II trial with eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer
Acronym
Phase II trial with eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer
Scientific Title
Phase II trial with eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer
Scientific Title:Acronym
Phase II trial with eribulin and trastuzumab for advanced/recurrent 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
Efficacy and safety of eribulin and trastuzumab in patients with advanced/recurrent HER2-positive breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical benefit
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
Administration of eribulin with a dose of 1.4 mg/m2 for days1 and 8. Administration of trastuzumab every 3 weeks with a starting dose of 8 mg/kg followed by 6 mg/kg as the second and subsequent doses.
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
Female
Key inclusion criteria
1. Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination.
2. Advanced/reccurent HER2-positive breast cancer patients with clinical stage IIIb, IIIc, or IV.
3. Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI.
4. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
5. Patients with a performance status (ECOG) of 0, 1, or 2
6. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan).
7. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration.
(1)Neutrophil>=1,500/mm3
(2)Platelet>=100,000/mm3
(3)Hb>=9.0g/dL
(4)T-BIL<=2.0mg/dL
(5)AST, ALT <=100IU/L
(6)Serum creatinine <= 1.5mg/dL
8. Patients expected to survive for 6 months or more.
9. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec).
10. Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria
1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer.
2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema.
3. Patients with brain metastases treatment is required at the time of registration.
4. Patients with serious co-morbidities
(1)Uncontrolled diabates
(2)Uncontrolled hypertension
(3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication.
(4)Ischemic heart disease, arrhythmias, valvular disease requiring medication.
(5)Liver dysfunction(jaundice)
(6)Renal dysfunction
(7)Active infection or fever suspicious of infection.
(8)Other serious complications
5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
The University of Tokushima graduate school
Division name
Department of Thoracic, Endocrine surgery and Oncology
Zip code
Address
Kuramoto 3-18-15
TEL
088-633-7141
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Tangoku |
Organization
The University of Tokushima graduate school
Division name
Department of Thoracic, Endocrine surgery and Oncology
Zip code
Address
Kuramoto 3-18-15
TEL
088-633-7141
Homepage URL
http://www.tksbizan.com/
tangoku@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima graduate school
Institute
Department
Personal name
Funding Source
Organization
The University of Tokushima graduate school
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
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 | 06 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 31 | Day |
Last modified on
| 2013 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012460
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