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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010844
Receipt No. 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

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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
Email

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/
Email tangoku@clin.med.tokushima-u.ac.jp

Sponsor
Institute The University of Tokushima graduate school
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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