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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034477
Receipt No. R000037970
Scientific Title Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/13

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Basic information
Public title Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Acronym KOEB2 trial
Scientific Title Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Scientific Title:Acronym KOEB2 trial
Region
Japan

Condition
Condition Eligible patients were those with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1, followed by HER + PER + eribulin.
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and safety of HER + PER + eribulin for patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall response rate: ORR
Key secondary outcomes progression-free survival: PFS
overall survival: OS
adverse events

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 female patients with diagnosis of breast cancer by histological or cytological examination.
2 ECOG performance status (PS) 0-2
3 with measurable disease lesion by RECIST
4 patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1 (other additional chemotherapy and endocrine therapy is allowed)
5 without previous eribulin treatment
6 with normal organ function
fulfill the criteria below of laboratory data in 7 days before register
6-1. neutrophils: more than 1,500/mm3
6-2. platelets: more than 100,000mm3
6-3. Hb: more than 9.0g/dL
6-4. total bilirubin: less than 2.0 mg/dL
6-5. AST (GOT), ALT (GPT), ALP: less than 2.5 ULN
6-6. serum creatinine: less than 1.5 mg/dL
7 prognosis of more than 3 months is expected
8 no clinical problem with ECG
9 who agreed to register in this trial with written consent
Key exclusion criteria 1 infection
2 severe allergy for medication
3 severe heart, renal, liver dysfunction
4 interstitial pneumonia or pulmonary fibrosis
5 large amount of pleural effusion or ascites
6 hypertension or diabetes that is poorly controlled
7 under steroid therapy
8 pregnant woman
9 who received transfusion, blood products, and hematopoietic factor products within 7 days
10 active double cancer (simultaneous double cancer and metachronous cancer within 5 years except for carcinoma in situ and intramucosal cancer)
11 history of psychiatric or CNS disorders which casts clinical problems
12 diagnosis or suspect of brain metastasis
13 engaging in other clinical trials
14 when responsible doctors made a judgement of inappropriate patient
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsu Hayashida
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Email tetsu@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takamichi Yokoe
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email takamichi.yokoe@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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
2018 Year 11 Month 01 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
2018 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registration period: 2 years
Follow-up period: 5 years

Management information
Registered date
2018 Year 10 Month 13 Day
Last modified on
2018 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037970

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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