UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012350 |
|---|---|
| Receipt number | R000014439 |
| Scientific Title | Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer |
| Date of disclosure of the study information | 2013/11/20 |
| Last modified on | 2023/12/02 21:08:35 |
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Basic information
Public title
Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer
Acronym
Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer
Scientific Title
Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer
Scientific Title:Acronym
Phase II study of eribulin with trasutuzumab for pretreated locally advanced / metastatic HER2-positive breast cancer
Region
| Japan |
Condition
Condition
locally advanced / metastatic HER2-positive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We confirm the effectiveness and safety of combination therapy with eribulin and trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
objective response rate
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 1.4mg/m2 for days 1 and 8. Administration of trastuzumab every 3 weeks or weekly with a starting dose of 8mg/kg (weekly; 4mg/kg) followed by 6mg/kg (weekly; 2mg/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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1)Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination.
(2)Patients with a performance status (ECOG) of 0, 1, or 2
(3)HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
(4)Patients using chemo agents or trastuzumab as 1st line therapy of advanced/reccurent breast cancer.
(5)Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI.
(6)Patients with adequately maintained organ functions.
(7)Patients fulfilling the following conditions within 14 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 < 2.5 x ULN (Patients with liver metastases; < 5.0 x ULN)
6. Serum creatinine <= 1.5mg/dL
7. non-hematologic toxicity <= Grade2 (except for alopecia)
(8)Patients expected to survive for 6 months or more.
(9)Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan) within 28 days before registration.
(10)Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec) within 28 days before registration.
(11)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 diagnosed as having unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmia requiring medication within 6 months before registration.
(4)Patients with uncontrolled complications(malignant hypertension,infection,hemorrhagic tendency,diabates)
(5)Active infection or fever suspicious of infection
(6)Severe renal dysfunction and liver dysfunction (jaundice)
(7)History use of eribulin
(8)Patients with uncontrollable brain metastases
(9)HBs antigen positive (case of the anti-HBs or anti-HBc positive patients in HBs antigen negative, for adding precision inspection and administration of nucleic acid analog, do at the discretion of each facility)
(10)Patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nagino |
Organization
Nagoya University
Division name
Division of Surgical Oncology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Tsunoda |
Organization
Nagoya University
Division name
Division of Surgical Oncology
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2222
Homepage URL
nobtsun@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Nagoya University Certified Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
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 | 11 | Month | 20 | 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 | 11 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014439
