UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012232 |
|---|---|
| Receipt number | R000014129 |
| Scientific Title | A study of eribulin in combination with trastuzumab and pertuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer |
| Date of disclosure of the study information | 2013/11/07 |
| Last modified on | 2021/07/15 15:45:33 |
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Basic information
Public title
A study of eribulin in combination with trastuzumab and pertuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer
Acronym
JBCRG-M03
Scientific Title
A study of eribulin in combination with trastuzumab and pertuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer
Scientific Title:Acronym
JBCRG-M03
Region
| Japan |
Condition
Condition
First or second line therapy for advanced or recurrent HER2-positive breast cancer patients who have received taxane and trasutuzumab as adjuvant or recurrent therapy.
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of eribulin in combination with trastuzumab and pertuzumab as first line or second line 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,Overall survival(OS),Efficacy after prior use of pertuzumab,Compliance of eribulin, Efficacy of later therapy
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,trastuzumab, and pertuzumab 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
| 18 | years-old | <= |
Age-upper limit
| 71 | years-old | > |
Gender
Female
Key inclusion criteria
1.Histologically confirmed primary breast cancer
2.Age of 18-70 years and expected survival is more than 6months
3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH)
4.First or second line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer
5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases)
6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone
7.Experienced prior chemotherapy including trasutuzumab and taxane(Prior pertuzumab allowed to be use)
8.No prior use of eribulin
9.Adequate organ function shown in physical examinations within 14 days prior to enrollment
Neutrophil count >=1500/mm3
Platelet count >=75,000/mm3
Hemoglobin >=9.0g/dL
Total serum bilirubin <=2.0mg/dL
AST and ALT <100IU/L
Serum creatinine <=1.5mg/dL
10.No clinical electrocardiographic abnormality
11.Echocardiographic ejection fraction >=55%
12.Subjects who have submitted written informed consent for study entry
Key exclusion criteria
1.Active infection or fever at risk of infection
2.History of serious drug allergies
3.Spontanous serious renal damage or liver dysfunction(jaundice)
4.Iinterstitial pneumonia or pulmonary fibrosis by chest X-ray
5.Large pleural effusion or ascites requiring repeat drainage
6.Concurrent uncontrolled hypertension or diabetes mellitus
7.Systemic administration of steroid drug
8.Pregnant females or females of child-bearing potential
9.Concurrent active other malignancy
10.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ
11.Clinically important mental disorder or history of central nervous system damage
12.Clinically significant central nervous system metastases
13.Concurrent enrollment of other clinical trial
14.History use of eribulin
15.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate
16.HBs antigen positive
17.Not suitable for participation with any other reasons
(including rapid progression disease, life threatening status if not successfully treated)
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Toshinari |
| Middle name | |
| Last name | Yamashita |
Organization
Kanagawa Cancer Center
Division name
Department of Breast and Endocrine Surgery
Zip code
241-8515
Address
2-3-2 Nakao, Asahi-ku, Yokohama, Japan
TEL
045-520-2222
tyamashita@kcch.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
Organization
JBCRG (Japan Breast Cancer Research Group)
Division name
Head Office
Zip code
103-0016
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
TEL
03-6264-8873
Homepage URL
https://www.jbcrg.jp/
office@jbcrg.jp
Sponsor or person
Institute
JBCRG(Japan Breast Cancer Research Group)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
東京都立駒込病院（東京都）、熊本赤十字病院（熊本県）、愛知県がんセンター中央病院（愛知県）、筑波大学附属病医院（茨城県）、りんくう総合医療センター（大阪府）、千葉大学医学部附属病院(千葉県)、大阪労災病院（大阪府）、浜松医療センター（静岡県）、九州がんセンター（福岡県）、松山赤十字病院（愛媛県）、横浜市立大学付属市民総合医療センター（神奈川県）、敬愛会 中頭病院（沖縄県）、長崎大学病院 腫瘍外科（長崎県）、青森市民病院（青森県）、静岡県立総合病院（静岡県）、青森県立中央病院（青森県）、神奈川県立がんセンター（神奈川県）、弘前市立病院（青森県）、名古屋市立大学病院（愛知県）、北海道大学病院（北海道）、関西医科大学附属枚方病院（大阪府）、関西電力病院（大阪府）、大阪赤十字病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 07 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | 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 | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014129
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